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FDAAugust 8, 2024device

Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-cemented femoral and acetabular components. Item Number: 650-1064

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

The hazard

Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6

What to do

FDA enforcement status: Ongoing

Brands named

zimmer

UPCs

00887868271465

Recall history

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

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