Reported Jun 14, 2017 · Terminated
DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various…
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?
- DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures
- Lot codes and dates
- Unknown
- Amount recalled
- 345
Where it was sold
Why it was recalled
Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. The safety or effectiveness of these devices cannot be assured.
This product could cause temporary or reversible health problems — stop using it.
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