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FDAJanuary 6, 2017device

DePuy Synthes various orthopedic instruments modified by U.S. Distributors These instruments are used in various orthopedic procedures

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

depuy orthopaedicsdepuy

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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