Recall Z-0569-2024 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Biomet, Inc.
Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
| Date | Dec 18, 2023 (initiated Nov 2, 2023) |
| Status | Open, Classified |
| Reason | One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE RECALL notification letter dated 11/2/23 was sent to customers. 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 the recall notice for hospitals and ensure documentation. 4. Complete Attachment 1 C |
| Quantity | 10 units |
| Distribution | US States: AL, CA, MD, MI, NC, OH, OK, TN, TX. Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200112 | Zimmer Hip Joint Replacement Zimmer GmbH, Apr 10, 2020 |