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Zimmer GmbH recalls Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-ce
Recalled September 18, 2024 · FDA recall Z-3133-2024 · Zimmer
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 · FDA Class II
Units
58 units
Sold at
Worldwide distribution - US Nationwide and the countries of Japan, Netherlands.
Description
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
Product
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
Manufacturer(s)
Zimmer GmbH
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →