FDA Enforcement
Class II
Ongoing
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
Recall: Z-3133-2024
·
Reported September 18, 2024
Enforcement
- Recall Number
- Z-3133-2024
- Event ID
- 95231
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Zimmer GmbH
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 18, 2024
- Initiation Date
- August 8, 2024
- Classification Date
- September 12, 2024
- Address
- Sulzerallee 8, Winterthur, N/A, Switzerland
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
Reason
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
Code Info
UDI: (01)00887868271465(17)331130(10)3185266 Lot Number: 3185266
Distribution
Worldwide distribution - US Nationwide and the countries of Japan, Netherlands.
Quantity
58 units