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

Agency Publication Date: October 25, 2013

Affected Products

Product: Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip.

Part Number Range: 00-5001-038/072-00

Product: CPT¿ Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SIZE 1 COCR; CPT 12/14 SIZE 1 COCR EXT CPT 12/14 STEM SIZE 2 COCR; CPT 12/14 SIZE 2 COCR EXT; CPT 12/14 SIZE 2 COCR 180MM; CPT 12/14 SIZE2 COCR XEXT; CPT 12/14 STEM SIZE 3 COCR; CPT 12/14 SIZE 3 COCR EXT; CPT 12/14 SZ 3 COCR 180MM EXT; CPT 12/14 SIZE 3 COCR XEXT; CPT 12/14 STEM SIZE 4 COCR; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SZ 4 COCR 230MM EXT; CPT 12/14 SZ 4 COCR 260MM EXT; CP

Part Number Range: 00-8114-000/050-00/30

Product: Versys¿ Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200MM 8ST; POR FULLCT FEM ST 11 LOW EXT; POR FULLCT FEM ST 11 EXT; POR FLCT FEM STEM LM 11X160MM; POR FULLCT LM FEM ST 11 EXT POR FULL-CT FEM ST 12X160MM VERSYS BEADED FC 12X200MM 8 ST POR FULLCT FEM ST 12 LOW EXT POR FLCT FEM ST 12.0X190 STR POR FULLCT FEM ST 12 EXT POR FULL-CT FEM ST LM 12X160MM POR FULLCT LM FEM ST 12 EXT POR FULL-CT FEM ST 13X160MM VERSYS HIP SYSTEM REVISION FEMORAL BEADED FULLCO

Part Number Range: 00-7843-011/022-06/56

Product: Metasul¿ Head. Intended for use either with or without bone cement in total hip arthroplasty.

Part Number Range:00-8770-040-01/05 & 01.01062.405/408

Product: CoCr Head (Not distributed in the United States) Used in total hip replacement.

Part Number Range:01.01012.405/408

Product: NexGen¿ Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ C-R MINUS ;CR-FLEX GSF PRECOAT SZ D-L; CR-FLEX GSF PRECOAT SZ D-R ;CR-FLEX GSF PCT SZ D-L MINUS ; CR-FLEX GSF PCT SZ D-R MINUS ;CR-FLEX GSF PRECOAT SZ E-L CR-FLEX GSF PRECOAT SZ E-R ;CR-FLEX GSF PCT SZ E-L MINUS ;CR-FLEX GSF PCT SZ E-R MINUS ;CR-FLEX GSF PRECOAT SZ F-L ;CR-FLEX GSF PRECOAT SZ F-R ;CR-FLEX GSF PCT SZ F-L MINUS ;CR-FLEX GSF PCT SZ F-R MINUS ;CR

Part Number Range: 005750, 5764, 5950, 5952, 5956, 5960, 5962, 5964, 5966, 5970, 5972, 5990, 5992, 5994, and 5996-011/018-01/92.

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-FLE

Part Number Range: 5752 and 5762.

Product: Natural-Knee¿ Flex Femoral Component. Provides increased flexion capability.

Part Number Range: 00-5410,5412,5414,and 5416-013/018-01/02.

Product: Zimmer¿ Unicompartmental Knee Femoral Component. Indicated for patients with painful and/or disabling knee joint.

Part Number Range:00-5842-011/017-01/02

Product: Gender Solutions" Patello-Femoral Component

Part Number Range:00-5926-011/015-01/02

Product: Natural-Knee¿ II Femoral Component

Part Number Range:6212, 6307-00-006/051

Product: Sidus" Head (Not distributed in the United States)

Part Number Range: 01.04555.380/525

Product: NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States)

Part Number Range:005930-010/080-01/02

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 65799

Status: Resolved

Manufacturer: Zimmer, Inc.

Manufactured In: United States

Units Affected: 13 products (72806; 24561; 6380; 194 (8770-040); 604064 total; 604064 total; 11694; 33987; 32537; 5103; 13483; 0 in USA; 3475)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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