Reported Jan 24, 2018 · Terminated
Persona Partial Knee System, Size 8, Finishing Guide
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?
- Persona Partial Knee System, Size 8, Finishing Guide
- Lot codes and dates
- Item No. 42578100801, Lot No. 63518668, UDI (01)00880304809253(10)63518668. Item No. 42578100802, Lot No. 63518669, UDI (01)00880304809338(10)63518669.
- Amount recalled
- 158 devices
Where it was sold
Why it was recalled
Finishing guide does not adequately account for shape differences present in Size 8 of Persona Partial Knee System, potentially resulting in additional surgery time or sensation of tightness during knee flexion.
This product could cause temporary or reversible health problems — stop using it.
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