Reported May 1, 2024 · Ongoing
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a…
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: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid stock (outer barrier). The sealed double barrier system is placed into a paperboard carton with an IFU and label/indicator dots applied to the carton.
- Lot codes and dates
- Item Number189082
- Lot Number65966530
- UDI-DI(01)00880304436954(17)280413(10)65966530
- Amount recalled
- 19 units (1 US, 18 OUS)
Where it was sold
- Nationwide
- IN
Why it was recalled
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
This product could cause temporary or reversible health problems — stop using it.
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