Reported Aug 22, 2012 · Terminated
DePuy Custom Implant Devices Packaging: Packaging was not standardized on customs, it was dependant on the geometry of…
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 Custom Implant Devices PackagingPackaging was not standardized on customs, it was dependant on the
- geometry of the product Product UsageDescription: Devices meeting the regulatory definition of a custom medical device are those which are provided by prescription at a physician s request to meet a specific patient need and have been exempt from FDA premarket review under the Federal Food, Drug, and Cosmetic Act since 1976
- Intended UseSee information contained in the Information for Use for Custom Implant Device (IFU-0902-00-500 rev C)
- Lot codes and dates
- Part Number
2,963 of 2,963 codes
101178997101201997101201998101201999101201999101214999101402998101402999101403999101436996101436997101466996101466997101466997101466997101466997101467996101467997101467997101467997101467997101467998101468997101468997101468997101468997101468999101469996101469997101469997101469997101469997101469997101470996101470997101470997101470997101470997101470999101471997101471997101471997101471997101471997101472990101472991101472992101472993101480961101480962101480963101480964101480977101480978101480983101480984101480985101480988101480989101480992
- Part Number
- Amount recalled
- 8338
Where it was sold
Why it was recalled
In connection with a Warning Letter received from the U.S. Food & Drug Administration on December 9, 2011, DePuy Orthopaedics is taking steps to retrieve custom device implants that surgeons may have ordered from DePuy Orthopaedics, but not implanted. DePuy Orthopaedics received a Warning Letter from the FDA on December 9, 2011 regarding custom device implants. DePuy Orthopaedics has discontinue
This product could cause temporary or reversible health problems — stop using it.
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