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
Z-3133-2024
Product summary
- Firm
- Zimmer GmbH
- Event
- Event 95231
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 58 units
- Official record key
device-enforcement:Z-3133-2024
Official wording
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 information: UDI: (01)00887868271465(17)331130(10)3185266 Lot Number: 3185266
Distribution pattern: Worldwide distribution - US Nationwide and the countries of Japan, Netherlands.
Derived failure modes
-
Labeling or packaging
Mislabeled