Recall Z-0336-2020 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Zimmer Biomet, Inc.
Ceramic Femoral Heads, various sizes, Item Nos. 00877504001 00877504002 00877504003 00877504004
| Date | Oct 10, 2019 |
| Status | Terminated |
| Reason | Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration). |
| Root cause | Packaging change control |
| Action | The firm distributed Urgent Medical Device Correction letters to customers on October 10, 2019. The letter informed customers that the previous version of low density polyethylene (LDPE) bag could potentially adhere to the surface of metal devices. Please note, this is separate from the previous recall for highly polished implants packaged in the previous version of the LDPE bags. Customers were asked to take the following actions: 1. Review this notification and ensure that pertinent personnel are aware of the contents. 2. Ensure that backup devices for the affected products are available, |
| Quantity | 5,459,583 total devices |
| Distribution | Distributed nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071535 | BIOLOX DELTA CERAMIC FEMORAL HEAD Zimmer, Inc., Nov 19, 2007 |