Recall Z-0312-2020 ยท HRS Plate, Fixation, Bone
Zimmer Biomet, Inc.
Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 47492800402 47492800403 47492800407 47492800502 47492800503 47492800507 47492800603 47492800607 47492800613 47492800702 47492800703 47492800707 47492800802 47492800803 47492800807 47492800813 47492800902 47492800907 47492801002 47492801007 47492801013 47492801207 47492801213 47492801413 47492801607 47492801613 47492801702 4749280
| 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
| K060710 | UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS Zimmer, Inc., Apr 26, 2006 |
| K063303 | UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS Zimmer, Inc., Nov 22, 2006 |
| K082527 | ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS Zimmer, Inc., Dec 18, 2008 |
| K083654 | ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM) Zimmer, Inc., Feb 26, 2009 |