Biolox Option Taper Sleeve recalled over labeling errors

Recall date

August 8, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Zimmer GmbH recalls Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck - Indicated for use in total hip replacement with cemented or non-c…

Recall number

Z-3133-2024

FDA classification

Class II

Brand / firm

Zimmer GmbH

Sold / distributed

Worldwide distribution - US Nationwide and the countries of Japan, Netherlands.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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