Reported Sep 5, 2018 · Terminated
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
DePuy Orthopaedics, 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: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
- Lot codes and dates
- LotC2KJ24
- GTIN10603295234135
- Amount recalled
- 1
Why it was recalled
This unit may be missing the screw/collet Assembly
This product could cause temporary or reversible health problems — stop using it.
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