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FDADecember 21, 2017device

(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 1060329500163...

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

The hazard

The SIGMA¿ HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company s post market surveillance process.

What to do

FDA enforcement status: Terminated

Brands named

depuy orthopaedicsdepuy

UPCs

10603295001614106032950016211060329500163810603295001645106032950016521060329500166910603295001676106032950016831060329500169010603295001706

Recall history

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

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