Recall Z-3133-2024 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Zimmer GmbH
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
| Date | Sep 12, 2024 (initiated Aug 8, 2024) |
| Status | Open, Classified |
| 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 |
| Root cause | Under Investigation by firm |
| Action | Zimmer issued Urgent Medical Device Recall letter on 8/8/24 to Distributors, Risk Managers and Surgeons. Letter states reason for recall, health risk and action to take: Risk Manager Responsibilities: 1.Review this notification and ensure that affected personnel are aware of the contents. 2.If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with this no |
| Quantity | 58 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Japan, Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082996 | BIOLOX DELTA OPTION CERAMIC HEADS Biomet, Inc., Jan 15, 2009 |