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FDAOctober 15, 2024device

Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.

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

The hazard

The Bipolar assembly contains an oversized Retainer Ring.

What to do

FDA enforcement status: Ongoing

Brands named

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UPCs

03596010494375

Recall history

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

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