The Recall Desk

FDA (Devices) recall action 65799

Zimmer, Inc. recalled 13 products on 2013-11-06

The FDA (Devices) publishes a recall like this one as 13 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 13 pages.

Products
13
Announced
2013-11-06
Critical
0
Units
1,412,154

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–13 of 13

  • ModerateFDA (Devices)··2013-11-06

    Zimmer Recalls CPT Femoral Stems Due to Packaging Adhesion Issue

    Zimmer, Inc. is recalling CPT Femoral Stems because the low-density polyethylene packaging bags adhere to the polished device surfaces.

    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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-11-06

    Zimmer Recalls NexGen Femoral Components Due to Packaging Adhesion

    Zimmer, Inc. is recalling NexGen femoral components because the packaging bags adhere to the device surfaces.

    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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-11-06

    Zimmer Sidus Head Recall Due to Packaging Adhesion Issue

    Zimmer, Inc. is recalling Sidus Heads because the packaging bags adhere to the device surfaces. No units were distributed in the United States.

    Product
    Sidus" Head (Not distributed in the United States)
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-11-06

    Zimmer Recalls NexGen Femoral Components Due to Packaging Adhesion

    Zimmer, Inc. is recalling NexGen Femoral Components because the packaging bags adhere to the device surfaces. The recall covers 11,694 units distributed worldwide.

    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…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-11-06

    Zimmer Multipolar Bipolar Cup Metal Shell Recall Due to Packaging Adhesion

    Zimmer, Inc. is recalling Multipolar Bipolar Cup Metal Shell implants because the packaging bag adheres to the device surface.

    Product
    Multipolar¿ Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-11-06

    Zimmer Recalls Metasul Head Implants Due to Packaging Adhesion Issue

    Zimmer, Inc. is recalling Metasul Head implants because the low-density polyethylene packaging bags adhere to the device surfaces.

    Product
    Metasul¿ Head. Intended for use either with or without bone cement in total hip arthroplasty.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-11-06

    Zimmer Recalls CoCr Hip Replacement Heads Due to Packaging Adhesion

    Zimmer, Inc. is recalling CoCr heads used in total hip replacements because the packaging bags adhere to the device surfaces.

    Product
    CoCr Head (Not distributed in the United States) Used in total hip replacement.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-11-06

    Zimmer Natural-Knee Flex Femoral Component Packaging Adhesion Recall

    Zimmer, Inc. is recalling Natural-Knee Flex Femoral Components because the low-density polyethylene packaging bags adhere to the polished device surfaces.

    Product
    Natural-Knee¿ Flex Femoral Component. Provides increased flexion capability.
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-11-06

    Zimmer Unicompartmental Knee Femoral Component Packaging Recall

    Zimmer, Inc. is recalling knee implant components because the packaging bags adhere to the device surfaces.

    Product
    Zimmer¿ Unicompartmental Knee Femoral Component. Indicated for patients with painful and/or disabling knee joint.
    Category
    Distribution
    0 states
  • LowFDA (Devices)··2013-11-06

    Zimmer Versys Femoral Stem Recall Due to Packaging Adhesion

    Zimmer, Inc. is recalling Versys Beaded Fullcoat Femoral Stems because the packaging bag adheres to the polished device surface.

    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…
    Category
    Distribution
    0 states