Zimmer GmbH: Device Recall

Recall #Z-3133-2024 · 08/08/2024

Class II: Risk

Recall Details

Recall Number: Z-3133-2024
Classification: Class II
Product Type: Device
Recalling Firm: Zimmer GmbH
Status: Ongoing
Date Initiated: 08/08/2024
Location: Winterthur, Switzerland
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 58 units

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

Product Description

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

Distribution Pattern

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

Other Recalls by Zimmer GmbH

Class II: Risk 08/08/2024

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

View all recalls by Zimmer GmbH →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.