PlainRecalls
FDA Devices Moderate Class II Terminated

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-FLE

Reported: November 6, 2013 Initiated: August 30, 2013 #Z-0074-2014

Product Description

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 for Recall

The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

Details

Recalling Firm
Zimmer, Inc.
Units Affected
11694
Distribution
Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Zimmer, Inc.. Units affected: 11694.
Why was this product recalled?
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 6, 2013. Severity: Moderate. Recall number: Z-0074-2014.