Events

Recall of INFUSE BONE GRAFT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDTRONIC OF CANADA LTD..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    24947
  • Event Risk Class
    II
  • Event Initiated Date
    2013-06-13
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    Product associated with a voluntary recall being conducted by integra lifesciences corporation. specifically integra life sciences corporation has recalled certain lots of the absorbable collagen sponge (acs) which is a component of the infuser bone graft kit. integra lifesciences corporation announced the voluntary recall advising us as follows: "integra life sciences has identified through an internal quality assurance review of processes that we may have deviated from a production process during the manufacture of specific lots of product. accordingly we are recalling those specific lots. the product lots in question passed all product finished goods testing are sterile and were tested and accepted for endotoxin levels. however due to the process deviation they may have been released with higher levels of endotoxins than permitted by the specifications for the products. higher endotoxin levels may result in a fever in the immediate postoperative period. we are not aware of any reports of patient injuries or other adverse events in connection with these product lots. however if you have already implanted or used collagen sponge products affected by this recall we recommend you monitor the patient for a fever in the immediate postoperative period according to the standard hospital or clinician protocol.".

Device

INFUSE BONE GRAFT
  • Model / Serial
    Model Catalog: 7510200 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 7510400 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 7510600 (Lot serial: > 10 lot numbers contact mfg); Model Catalog: 7510800 (Lot serial: > 10 lot numbers contact mfg)
  • Product Description
    INFUSE BONE GRAFT
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Manufacturer Address
    BRAMPTON
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    HC