Recall Z-0328-2020 ยท HSB Rod, Fixation, Intramedullary And Accessories
Zimmer Biomet, Inc.
Various fixation systems and accessories, Item Nos. 00224000916 00224000918 00224000920 00224000922 00224000924 00224000926 00224000928 00224000930 00224000932 00224000934 00224000936 00224000938 00224000940 00224000942 00224000944 00224000946 00224001014 00224001016 00224001018 00224001020 00224001022 00224001024 00224001026 00224001028 00224001030 00224001032 00224001034 00224001036 00224001038
| 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
| K142281 | ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM Zimmer, Inc., Oct 22, 2014 |