Events

Safety Alert Or Field Safety Notices for DePuy SmartSeal™ pressurisers- femoral and acetabular pressurisers (5 pack)

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by DePuy CMW.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2007/081
  • Event Number
    CON2032850
  • Date
    2007-10-25
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2032850
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Recall of smartseal™ pressuriser as the outer pouch seal may be compromised. depuy cmw is recalling smartseal™ pressurisers used during cemented total hip joint replacement surgery, because the outer peelable pouch seals may be creased and therefore may not be intact. the inner peelable pouch seals are intact and therefore the device is likely to remain sterile. depuy cmw is recalling this product as a precautionary measure. the manufacturer is currently investigating the root cause of the packaging problem. the mhra is not aware of any incidents associated with these affected devices. the manufacturer estimates that about 15,000 potentially affected devices have been distributed in the uk since april 2005. the manufacturer wrote to users about this recall in july 2007 (see mhra website). however, only 5% of the affected devices had been returned to the manufacturer by 04 october 2007. this notice is intended to facilitate the manufacturer’s recall.
  • Action
    Identify and quarantine affected devices. Do not use affected devices. Return affected devices to the manufacturer.

Device

DePuy SmartSeal™ pressurisers- femoral and acetabular pressurisers (5 pack)
  • Model / Serial
  • Product Description
    Orthopaedic bone cement restrictor instrumentation. DePuy SmartSeal™ pressurisers- femoral and acetabular pressurisers (5 pack) manufactured by DePuy CMW. DePuy SmartSeal™ pressuriser: femoral and acetabular pressurisers (5 pack)  for use with orthopaedic bone cement. Part numbers 3206045 – 45mm acetabular pressuriser 3206052 – 52mm acetabular pressuriser 3206055 – 55mm acetabular pressuriser 3206060 – 60mm acetabular pressuriser 3206065 – 65mm acetabular pressuriser 3206002 – wedge femoral pressuriser 3206005 – standard femoral pressuriser Lot numbers - all lot numbers are affected by this recall. Any DePuy SmartSeal pressurisers that have a black tick on the bottom right hand corner of the pouch and on the carton have already been re-inspected by DePuy CMW and the manufacturer has verified that the seals are fully intact. These products are now excluded from the recall.
  • Manufacturer
    DePuy CMW

Manufacturer

DePuy CMW