Zimmer GmbH Recall 95231
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
Zimmer GmbH Recall 95231 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-3133-2024 |
Event ID | 95231 |
Event 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 |
Product Type | Devices |
Distribution | Worldwide distribution - US Nationwide and the countries of Japan, Netherlands. |
Quantity | 58 units |
Recall 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 |
Device Classification | 20240918 |
Device Code Info | UDI: (01)00887868271465(17)331130(10)3185266 Lot Number: 3185266 |
Center Classification Date | 20240912 |
Recall Initiation Date | 20240808 |
Recalling Firm | Zimmer GmbH |
Initial Notification | Letter |
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