Recall Z-0304-2020 ยท HRS Plate, Fixation, Bone
Zimmer Biomet, Inc.
NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009 0202263012 0202263015 0202263018 0202263021 0202263109 0202263112 0202263115 0202263118 0202263121 0202264009 0202264012 0202264015 0202264018 0202264021 0202264109 0202264112 0202264115 0202264118 0202264121 0202265010 0202265012 0202265014
| 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
| K100111 | NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM Zimmer, Inc., Apr 12, 2010 |