Class II

Medical Device Recall: 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

Zimmer GmbH · August 8, 2024

Reason for Recall

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

Distribution

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

States Affected

NATIONWIDE

Quantity Affected

58 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-3133-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.