Recall Z-0306-2020 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Zimmer Biomet, Inc.
TM Ankle and Ankle Talus L/R, Item Nos. 00450001100 00450001200 00450001300 00450001400 00450001500 00450001600 00450002100 00450002200 00450002300 00450002400 00450002500 00450002600
| 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
| K120906 | ZIMMER TRABECULAR METAL TOTAL ANKLE Zimmer, Inc., Aug 24, 2012 |