Product Wiki · Recalls · Health Canada — Medical Devices

Various Zimmer Biomet Polyethylene Implants (2017-02-22) — recall 56307

Health Canada — Medical Devices · Canada · 2017-02-23 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
56307
Date of alert
2017-02-23
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Zimmer Biomet is conducting a lot specific medical device field action for various polyethylene and ceramic implants. The affected products are being removed due to the potential presence of elevated endotoxin levels that exceed the specification limit. The issue was discovered during routine bacterial endotoxin testing (BET). There have been no complaints received, related to this issue. Endotoxins (pyrogens) are substances found in certain bacteria. The FDA-adopted standard for endotoxin levels is 20 EU/device. There were three samples during an approximate 6 week period that were found to exceed this level. As a result, the devices manufactured during this period are being removed.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/various-zimmer-biomet-polyethy

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