Product Wiki · Recalls · Health Canada — Medical Devices

Vanguard Knee System & RingLoc Hip System (2020-04-15) — recall 63384

Health Canada — Medical Devices · Canada · 2020-05-01 · Type II

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
63384
Date of alert
2020-05-01
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Zimmer Biomet is conducting a lot specific medical device recall for various polyethylene. In February 2017, Zimmer Biomet initiated a medical device recall for specific lots of various polyethylene implants. We recently discovered additional affected lots that may be in your inventory. 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 the additional affected lots. Endotoxins (pyrogens) are substances found in certain bacteria. The FDA-adopted standard for endotoxin levels is 20 EU/device. There were three polyethylene implant samples during an approximate 6-week period that were found to exceed this level. As a result, certain polyethylene implants manufactured between December 2016 and January 2017 are being removed. Affected products that have the potential to exceed process limits for endotoxins could present potential risks.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/vanguard-knee-system-ringloc-h

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.