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FDAMarch 29, 2018device

Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision.

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

The hazard

There is a potential for debris in the hole on the superior lateral aspect of the device as a result of machining which may not have been adequately removed during the subsequent cleaning process.

What to do

FDA enforcement status: Terminated

Brands named

zimmer biometzimmer

UPCs

00585003038

Recall history

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

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Zimmer Segmental System Proximal Femoral Component 38mm Offset, Model Number 00-5850-030-38 The Segmental System is used for solving complex salvage cases to address patients with severe bone loss associated with disease, trauma, or revision. — Recall Details · AllClear