The Recall Desk

Manufacturer

Zimmer, Inc.

446 recalls in our database name Zimmer, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
446
Critical
0
Severe
44
Most recent
2026-07-01

Of the 446 recalls from Zimmer, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 44 (10%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

276–300 of 446

  • HighFDA (Devices)·Z-2093-2013·2013-09-04

    Zimmer Recalls Versa-FX II Femoral Fixation System Due to Sterility Failure

    Zimmer, Inc. is recalling 85,794 units of the Versa-FX II Femoral Fixation System because a packaging configuration failed leak tests, compromising product sterility.

    Product
    VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short low profiles, several holes/length combinations (2/54, 3/70, 4/86, 5/102, 6/118) and several angles (130, 135, 140, 145 and 150). Item codes starting with 00-1193-130, 00-1193-135, 00-1193-140, 00-1193
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2101-2013·2013-09-04

    Zimmer Recalls Distal Medial Humeral Locking Plates Due to Labeling Error

    Zimmer is recalling specific lots of Distal Medial Humeral Locking Plates because the Chinese labels incorrectly identify right-sided implants as left-sided.

    Product
    ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLATE, SHORT RIGHT 11 HOLES 178 MM LENGTH STERILE RX ONLY Product Usage: Usage: The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotom
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-2028-2013·2013-08-28

    Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining knee implant components because surgeons are using them in unapproved combinations.

    Product
    00595204110 Articular Surface XLPE CR ART SURF 5-6/STRGRN 10, Rx, Sterile; 00595204112 Articular Surface XLPE CR ART SURF 5-6/STRGRN 12, Rx, Sterile; 00595204114 Articular Surface XLPE CR ART SURF 5-6/STRGRN 14, Rx, Sterile; 00595204117 Articular Surface XLPE CR ART SURF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2039-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597502010 Provisional AC ART SURF PROV 12/PUR 10, Rx, Sterile; 00597502012 Provisional AC ART SURF PROV 12/PUR 12, Rx, Sterile; 00597502014 Provisional AC ART SURF PROV 12/PUR 14, Rx, Sterile; 00597502017 Provisional AC ART SURF PROV 12/PUR 17, Rx, Sterile; 0059
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2042-2013·2013-08-28

    Zimmer NexGen Knee System Recalled for Unapproved Component Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597102010 Provisional CR ART SURF PROV 12/PURPLE 10, Rx, Sterile; 00597102012 Provisional CR ART SURF PROV 12/PURPLE 12, Rx, Sterile; 00597102014 Provisional CR ART SURF PROV 12/PURPLE 14, Rx, Sterile; 00597102017 Provisional CR ART SURF PROV 12/PURPLE 17, Rx, Ster
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2001-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining (CR) Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    65597201131 Femur CR POR FEM SURF HDN HATCP AML Rx, Sterile; 65597201132 Femur CR POR FEM SURF HDN HATCP AMR Rx, Sterile; 65597201231 Femur CR POR FEM SURF HDN HATCP BML Rx, Sterile; 65597201232 Femur CR POR FEM SURF HDN HATCP BMR Rx, Sterile; Used in total knee arth
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2013-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Due to Component Mismatch

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    65597201333 Femur CR POR FEM SURF HDN HATCP CML, Rx, Sterile; 65597201334 Femur CR POR FEM SURF HDN HATCP CMR, Rx, Sterile; 65597201433 Femur CR POR FEM SURF HDN HATCP DML, Rx, Sterile; 65597201434 Femur CR POR FEM SURF HDN HATCP DMR, Rx, Sterile; 65597201533 Femur CR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2037-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597106126 Provisional ALL POLY PAT PROV MICRO SZ 26, Rx, Sterile; 00597106129 Provisional ALL POLY PAT PROV MICRO SZ 29, Rx, Sterile; 00597106132 Provisional ALL POLY PAT PROV MICRO SZ 32, Rx, Sterile; 00597106135 Provisional ALL POLY PAT PROV MICRO SZ 35, Rx, Ster
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2025-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    90597003109 Articular Surface CR ART SURF 34/STR YEL 09MM, Rx, Sterile; 90597003110 Articular Surface CR ART SURF 34/STR YEL 10MM, Rx, Sterile; 90597003112 Articular Surface CR ART SURF 34/STR YEL 12MM, Rx, Sterile; 90597003114 Articular Surface CR ART SURF 34/STR YEL 14
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2008-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Sterile; 65595201202 Femur CR-FLEX POR HATCP FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2030-2013·2013-08-28

    Zimmer NexGen Knee System Recalled for Unapproved Component Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9, Rx, Sterile; 00597004110 Articular Surface CR ART SURF 56/STRIPE GREEN 10, Rx, Sterile; 00597004112 Articular Surface CR ART SURF 56/STRIPE GREEN 12, Rx, Sterile; 00597004114 Articular Surface CR ART SURF 56/ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2023-2013·2013-08-28

    Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR knee implant components because surgeons are using them in unapproved combinations. The recall covers 192,355 devices distributed in the US and Japan.

    Product
    90595203117 Articular Surface XLPE CR ART SURF AE34/STYEL 17, Rx, Sterile; 90595203120 Articular Surface XLPE CR ART SURF AE34/STYEL 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2020-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597202009 Articular Surface CR ART SURF 12/PURPLE 09, Rx, Sterile; 00597202010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597202012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597202014 Articular Surface CR ART SURF 12/PURPLE 14, Rx, Ster
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2038-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx, Sterile; 00597106129 Provisional MIC POROUS PAT PROV 29MMX10MM, Rx, Sterile; 00597106132 Provisional MIC POROUS PAT PROV 32MMX10MM, Rx, Sterile; 00597106135 Provisional MIC POROUS PAT PROV 35MMX10MM, Rx, Ster
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2002-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining (CR) Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597201131 Femur CR POR SURF HDN FEM CO-NID AML Rx, Sterile; 00597201132 Femur CR POR SURF HDN FEM CO-NID AMR Rx, Sterile; 00597201231 Femur CR POR SURF HDN FEM CO-NID BML Rx, Sterile; 00597201232 Femur CR POR SURF HDN FEM CO-NID BMR Rx, Sterile; Used in total knee
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2031-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations, specifically mixing micro and standard parts.

    Product
    90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; 90597004110 Articular Surface CR ART SURF AE56/STR GRN 10MM, Rx, Sterile; 90597004112 Articular Surface CR ART SURF AE56/STR GRN 12MM, Rx, Sterile; 90597004114 Articular Surface CR ART SURF AE56/ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved micro and standard combinations.

    Product
    90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 90597002010 Articular Surface CR ART SURF 12/PURPLE 10MM, Rx, Sterile; 90597002012 Articular Surface CR ART SURF 12/PURPLE 12MM, Rx, Sterile; 90597002014 Articular Surface CR ART SURF 12/PURPLE 14MM,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2016-2013·2013-08-28

    Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00595202010 Articular Surface XLPE CR ART SURF 1,2/PUR 10, Rx, Sterile; 00595202012 Articular Surface XLPE CR ART SURF 1,2/PUR 12, Rx, Sterile; 00595202014 Articular Surface XLPE CR ART SURF 1,2/PUR 14, Rx, Sterile; 00595202017 Articular Surface XLPE CR ART SURF 1,2/PUR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2024-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile; 00597003110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597003112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597003114 Articular Surface CR ART SURF 34/STRIPE Y
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2010-2013·2013-08-28

    Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597001333 Femur CR PRC SURF HDN FEM CO-NID CML Rx, Sterile; 00597001334 Femur CR PRC SURF HDN FEM CO-NID CMR Rx, Sterile; 00597001433 Femur CR PRC SURF HDN FEM CO-NID DML Rx, Sterile; 00597001434 Femur CR PRC SURF HDN FEM CO-NID DMR Rx, Sterile; 00597001533 Femu
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2017-2013·2013-08-28

    Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen Cruciate Retaining knee implant components because surgeons are implanting them in unapproved combinations.

    Product
    90595202017 Articular Surface XLPE CR ART SURF AE12/PUR 17, Rx, Sterile; 90595202020 Articular Surface XLPE CR ART SURF AE12/PUR 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2044-2013·2013-08-28

    Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations.

    Product
    00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597104112 Provisional CR ART SURF PROV 56/STR GRN 12, Rx, Sterile; 00597104114 Provisional CR ART SURF PROV 56/STR GRN 14, Rx, Sterile; 00597104117 Provisional CR ART SURF PROV 56/STR GRN 17, Rx,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2026-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597203109 Articular Surface CR ART SURF 34/STRIPE YEL 09, Rx, Sterile; 00597203110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597203112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597203114 Articular Surface CR ART SURF 34/STRIPE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1998-2013·2013-08-28

    Zimmer NexGen Knee System Components Recalled for Unapproved Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.

    Product
    00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; 00597001102 Femur CR PRECOAT FEM COMP SIZE AMR, Rx, Sterile; 00597001201 Femur CR PRECOAT FEM COMP SIZE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2003-2013·2013-08-28

    Zimmer NexGen Knee System Recall Due to Unapproved Component Combinations

    Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved micro and standard combinations.

    Product
    65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Femur CR POR FEM HATCP SIZE AMR Rx, Sterile; 65597201201 Femur CR POR FEM HATCP SIZE BML Rx, Sterile; 65597201202 Femur CR POR FEM HATCP SIZE BMR Rx, Sterile; Used in total knee arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide