Events

Recall of MEDPOR BARRIER IMPLANT

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

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
    94010
  • Event Risk Class
    II
  • Event Initiated Date
    2014-12-29
  • 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
    Stryker has become aware that there is a higher occurrence rate of implant damaged during intra-operative handling. a higher occurrence rate of implants breakage intra-operatively may be experienced. for the barrier sheets a loss of adhesion between the barrier sheet and the porous sheet may be also experienced during intra-operative handling and modification. stryker has become aware that the barrier location is on incorrect side of implant for part number 81036. the barrier is incorrectly situated on the inferior (bottom) surface of the implant instead of the superior (top) surface when the implant is properly oriented in the patient's right orbit.

Device

MEDPOR BARRIER IMPLANT
  • Model / Serial
    Model Catalog: 9312 (Lot serial: A1402023); Model Catalog: 9305 (Lot serial: A1402023); Model Catalog: 9312 (Lot serial: A1312011); Model Catalog: 9305 (Lot serial: A1312011); Model Catalog: 9312 (Lot serial: A1311044); Model Catalog: 9305 (Lot serial: A1311044); Model Catalog: 9312 (Lot serial: A1311008); Model Catalog: 81036 (Lot serial: A1402020); Model Catalog: 9312 (Lot serial: A1310051); Model Catalog: 9305 (Lot serial: A1310051); Model Catalog: 9312 (Lot serial: 81799); Model Catalog: 9305 (Lot serial: 81799); Model Catalog: 9312 (Lot serial: 77004); Model Catalog: 9305 (Lot serial: 77004); Model Catalog: 9312 (Lot serial: 69698); Model Catalog: 9305 (Lot serial: 69698); Model Catalog: 86001 (Lot serial: A1404026); Model Catalog: 86001 (Lot serial: A1405048); Model Catalog: 81036 (Lot serial: A1405060); Model Catalog: 9305 (Lot serial: A1404010); Model Catalog: 9312 (Lot serial: A1404010); Model Catalog: 9305 (Lot serial: A1403008); Model Catalog: 9312 (Lot serial: A1403008); Model Catalog: 9305 (Lot
  • Product Description
    MEDPOR BARRIER IMPLANT
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Manufacturer Address
    HAMILTON
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    HC