FDA Device recall Z-0074-2014
NexGen¿ Femoral Component (CR-FLEX GSF POR FEM, C-L
- FDA Device
- Class II
- terminated
- Published 2013-11-06
On 2013-11-06 the FDA classified a Class II recall of NexGen¿ Femoral Component (CR-FLEX GSF POR FEM, C-L 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-0074-2014 |
| 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¿ Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R; CR-FLEX GSF POR FEM, C-L MINUS; CR-FLEX GSF POR FEM, C-R MINUS; CR-FLEX GSF POR FEM, D-L; CR-FLEX GSF POR FEM, D-R CR-FLEX GSF POR FEM, D-L MINUS; CR-FLEX GSF POR FEM, D-R MINUS CR-FLEX GSF POR FEM, E-L; CR-FLEX GSF POR FEM, E-R; CR-FLEX GSF POR FEM, E-L MINUS; CR-FLEX GSF POR FEM, E-R MINUS; CR-FLEX GSF POR FEM, F-L ; CR-FLEX GSF POR FEM, F-R; CR-FLEX GSF POR FEM, F-L MINUS; CR-FLEX GSF POR FEM, F-R MINUS; CR-FLEX GSF POR FEM, G-L CR-FLEX GSF POR FEM, G-R; CR-FLEX GSF POR FEM, G-L MINUS CR-FLEX GSF POR FEM, G-R MINUS; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE C, LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE C, RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE D, LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE D, RIGHT; LPS-FLEX GSF POR FEM, E-L; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE E, RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE G, LEFT; and NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE G, RIGHT). Provides increased flexion capability.
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: 5752 and 5762. |
|---|
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-0074-2014%22
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