FDA recall Z-3133-2024

Zimmer GmbH · Class II · device

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

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.

Key facts

Status
Ongoing
Initiation date
2024-08-08
Report date
2024-09-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Winterthur, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3133-2024