Reported Jul 4, 2018 · Terminated
Vanguard Complete Knee System; E1 Vanguard PS Tibial Bearing; Model Numbers EP-183664, EP-183642 Product Usage: The…
Zimmer Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
Vanguard Complete Knee SystemE1 Vanguard PS Tibial BearingModel Numbers EP-183664
- EP-183642 Product UsageThe product is intended for use in knee joint replacement arthroplasties
- Lot codes and dates
- Lots 198810 and 210320
- Amount recalled
- 48
Where it was sold
Why it was recalled
Two lots of tibial bearings were commingled. There is a possibility that a 14mm tibial bearing is packaged in a box labeled as 12 mm tibial bearing and vice versa. This may lead to extension of surgery to find another implant.
This product could cause temporary or reversible health problems — stop using it.
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