FDA Device recall Z-0080-2014
NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)
- FDA Device
- Class II
- terminated
- Published 2013-11-06
On 2013-11-06 the FDA classified a Class II recall of NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States) by Zimmer, citing the low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0080-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-30 |
| Published | 2013-11-06 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)
Reason
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Identifiers
| code_info | Part Number Range:005930-010/080-01/02 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0080-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.