Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
We would like to emphasize the importance of following the instructions described in this letter in order to avoid
potentially erroneous results. in the worst case, this failure mode could result in a complete or partial dispense
failure of a reagent critical to the staining reaction (e.G. ultraview or optiview hrp). this in turn could result in
light or absent staining.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
This notice is to inform you about important information concerning updates to the
instructions for use (ifu) for the above products.
vascutek ltd has taken the opportunity to conduct a full review of the ifu contents to
ensure consistency across all product families and to ensure that the instructions for
use provide state of the art instruction and content to users. as a result of these
updates, further clarity will be provided to clinicians regarding immersion of grafts in
saline solution, and to enhance knowledge on the use of formaldehyde in the
manufacturing process. further details are provided overleaf,.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
Investigation of a recent complaint has made vascular solutions, inc. aware of a potential problem with the click
version of our guardian ii hemostasis valve. the low pressure seal may not close properly, which may allow air to
be introduced into the device and may lead to risk of an air embolism. no air ingress or patient harm has been
reported; however, due to the potential harm vsi is voluntarily recalling guardian ii hemostasis valves
manufactured with the following lot number(s): .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
Varian has received several reports of the on-board imager® cone beam ct [cbct] acquisition stalling
preventing reconstruction of the image. a repeat scan will be required. there are two possible symptoms.
1) the cbct application stops updating the display during acquisition.
2) an exception occurs during the acquisition.
although cbct projections will have been acquired, it will not be possible to generate the reconstructed cbct
and the scan must be repeated. there have been no misadministration or injuries reported due to this issue.
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
We have received occasional complaints of betafine universal pen needles 30g-8mm with lot
number 513061 and have therefore decided to proactively take action and recall this product.
sporadically, the steel cannula becomes stuck in the rubber seal of the pen’s insulin cartridge
after insulin injection. in such instances, there exists a slight danger of pricking oneself with the
already used cannula. the cause has already been established and resolved and therefore we
can assure you that only pen needles from lot number513061 can be affected by this issue.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
Shenke medical has identified a potential problem with the benefusion infusion pump (benefusion vp1 in benefusion vp3) in the plastic screw connection used to secure the pump housing as it may break under certain conditions. in the internal test
wear and tear has shown that broken plastic screw joints in red can support abnormal infusion flow management. in different cases, the dose of the infusion can be checked.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
Fol/owing several ruptures regarding some products, the presence of a potential defect was identified around
the orifices of the titanium plate regarding the batches referenced above, and that could generate a risk of
braid laceration during use.
this risk is particularly high when using a transtibial approach.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
Following a report received fron a customer and subsequent controls, became aware of the presence of
a leackage in the filling port of a small percentage of devices belonging to the lots listed below.
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
We, ekf-diagnostic gmbh, manufacturer of the biosen glucose/lactate analyzers and
corresponding consumables have been made aware of possible counterfeit products being made
available to the russian market. the products in question are provided in the following table.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
In 2017, the following incident involving a hase bikes trailer kit was reported to us: a child seated
in a trike that was being pulled as a trailer took their hands off the handlebars and touched one of
the brake discs, injuring themselves. this was the first incident of its kind to be reported to hase
bikes.
the associated risk only applies to models without rear suspension.
in response to this incident, we would like to ensure that all users are informed that children who
are being pulled in the trix/ketmiesel/trets must be instructed by the accompanying adult to keep
their hands on the handlebar grips at all times and never touch the brake discs or wheels.
.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
The control low (control l) and control high (control h) in kit 08102cp total ige-hrp eia with kit
lot 1812804cp show different lot numbers on the labels and on the quality control certificate
(qcc):
labels: 070505l and 070505h
qcc: 900505l and 900505h
the lot number shown on the qcc is correct for each control. the lot number on the labels is
wrong.
the functionality of the controls is not affected. they can still be used. the data on the qcc apply.
other kit lots are not affected. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
N-acetylcysteine (nac - used for treating excess intake of acetaminophen), n-acetyl—p—benzoquinone imine (napqi - a metabolite of acetaminophen) or metamizole administered in therapeutic concentrations may cause interferences in so-called trinder reactions when they are still present in the sample.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
The ce certificate of all young is invalid. we were informed by the
ansm (french health authorities) on 10th november 2016. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
Upon review of twenty-two non-injury customer complaints, zimmer surgical sa identified a potential malfunction on the above referenced handpieces. it is possible that the handpiece could start by itself when the power source is connected. the unexpected output of the device (start by itself) could lead to an injury to the user during usage or preparation of the device. please note that the actual complaint rate for this occurrence is 0.5% per distributed device, and no injuries have been reported.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
As a precautionary measure, zimmer gmbh is initiating a voluntary recall of certain batches of
the above referenced revitan proximal spout stems (size 55-105) and revitan proximal
cylindrical stems (size 55-105), because the thread spacing of the products might be out of
specification.
during the annual recalibration process of an inspection tool (thread plug gauge), used for a
process control during manufacturing of the revitan stem threads, it was detected that the
inspection tool was out of specification. .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
Zimmer biomet is conducting a lot specific medical device field action for vanguard open box
femoral components due to inadequate line clearance at the supplier between april 5, 2016 and
september 1, 2016. as a result, the packaging of some femoral components was incorrectly labeled
as either smaller or larger and/or as the incorrect side (right/left). it is highly detectable at the point of
use that the device was incorrectly labelled. the estimated rate of occurrence is 0.001% (<1 in 1000
products). .
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
Zimmer biomet is implementing a field-based action on medical devices for various polyethylene implants, depending on the lot. the products concerned are being withdrawn due to the possible presence of increased endotoxin levels beyond the specification limit. the problem was identified during routine testing for the presence of bacterial endotoxin (bet). no complaints were received regarding this issue.
endotoxins (pyrogens) are substances found in certain bacteria. the standard for endotoxin levels, as adopted by the us food and drug administration (fda), is 20 eu / gadget. three polyethylene sample implants were found to be in excess of this level over a period of about 6 weeks. as a result, polyethylene implants manufactured during this period are withdrawn from the market. the products concerned, which have the potential to exceed the limits for endotoxins, could pose the potential risks described below:.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
Ceramic hip systems have been used in complete hip arthroplasty for 2 years. however, in some cases and due to various factors, a second surgery may be necessary to break the ceramic part.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
An analysis showed 0.12% of cases in patients worldwide who had fractures of the tibial plateau.
an analysis of reported complaints has yielded results showing that, in the event of a fracture, tibia was identified by the orthopedic surgeon on average 25 days after the primary surgery, and available data indicates that 17% of these fractures were treated conservatively.
the cementless oxford tibial trays were manufactured according to predefined specifications. an investigation into the cause of reported tibial plateau fractures has shown that it is important to follow certain steps outlined in current surgical techniques to reduce the risk of tibial plateau fractures. this notice seeks to emphasize the importance of adhering to the applicable surgical technique and the relevant sections in the package leaflet.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
Optipac complaints were reviewed. the reported complaint rate for optipac is 0.0004% (for infections). it is up to the medical professional to evaluate whether a patient needs to be examined, but current results do not appear to require additional controls beyond the 2e standard.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
Zimmer biomet is issuing a safety notice for a medical device related to the packaging of selected versys hip and knee segments. the products in question were packaged in a previous version of the carton, which has not been tested for products weighing more than 487 grams. if the product exceeds the test weight, the integrity of the sterile barrier may be compromised. the products in question are only those that are packaged in an earlier version of the carton. this problem does not apply to products packaged in the latest packaging.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
There is a possibility that the foam used in the packaging of the products in question may be too small, which may pierce the internal cavity during transport. zimmer biomet has not received any complaints about the perforation of the internal cavity in the lots concerned.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
Zimmer biomet implements a voluntary medical device (withdrawal) measure for the tunneloc tibial fixation device group for validation testing of gamma sterilization associated with external vendors of the package indicating that the sterilization dose may not be appropriate.
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
Zimmer biomet sends a safety notification of medical devices for specific batches of tibial plate provisionals and tibial sizing plates to persona because of the possibility of sporadic cracks in the batch of raw materials used to manufacture the products in question. the purity of the products in question can be compromised if cracks appear on the surface of the instrument as a result of a raw material problem. for lists of products / batches to which this field measure relates, see annex 2 "list of related devices".
Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Slovenia.
Extra notes in the data
Reason
Zimmer biomet is conducting a medical device recall for the tibial augment bolts included in the
vanguard 360 revision knee system. the drill bit used to drill the hex pre-drilled hole in the screw
head was larger than allowable per the process specification. as a result, the hex geometry can still
be visible, but there are radial cuts into the hex flat which may prevent the bolt from being fully
tightened into the augment.
.