The Recall Desk

Hazard

Sterile Barrier Integrity recalls

24 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
24
Critical
0
Severe
0
Most recent
2022-06-01

Of the 24 sterile barrier integrity recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all sterile barrier integrity recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–24 of 24

  • HighFDA (Devices)·Z-1132-2022·2022-06-01

    Surgical Suture Kit Recalled for Uncertain Sterile Barrier Integrity

    Stradis Healthcare is recalling 7,340 units of Surgical Suture Kit due to uncertainty about sterilization methods that ensure sterile barrier integrity. Affected lots should not be used.

    Product
    Surgical Suture Kit
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1014-2014·2014-02-26

    Zimmer Recalls One-Piece Lag Screws Due to Packaging Validation Issues

    Zimmer is recalling 7,044,680 one-piece lag screws because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    ONE-PIECE LAG SCREW 11MM. Item codes starting with 00225900.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1036-2014·2014-02-26

    Zimmer Recalls CPT Degree Taper and Femoral HD Medical Devices

    Zimmer is recalling CPT Degree Taper and Femoral HD devices due to unvalidated packaging operations at a Puerto Rico facility.

    Product
    CPT DEGREE TAPER (various sizes) and FEMORAL HD (various sizes)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1016-2014·2014-02-26

    Zimmer Recalls Hip Prostheses Due to Unvalidated Packaging Operations

    Zimmer is recalling specific hip prosthesis models because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS 3, 4, 5 and 6.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1003-2014·2014-02-26

    Zimmer Recalls Free-Lock Orthopedic Devices Due to Packaging Validation Issues

    Zimmer is recalling specific Free-Lock orthopedic devices because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    FREE-LOCK LAG SCREW, 12.7, FREE-LOCK LAG SCREW, 15.8, FREE-LOCK SUPRACOND TUBE and FREE-LOCK TUBE & SCP PLAT. Items starting with codes 0011810 and 0011811.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1028-2014·2014-02-26

    Zimmer Recalls Versys Heritage Femoral Stems Due to Packaging Validation Issues

    Zimmer is recalling Versys Heritage Femoral Stems because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.

    Product
    VERSYS HERITAGE FEM STEM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1025-2014·2014-02-26

    Zimmer Recalls HGP II Acetabular Cup Due to Packaging Validation Issues

    Zimmer is recalling HGP II Acetabular Cup Bon due to unvalidated packaging operations at its Puerto Rico facility, despite passing seal integrity tests.

    Product
    HGP II ACETABULAR CUP BON
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1013-2014·2014-02-26

    Zimmer Recalls ITST Anti-Rotation Screws and Femoral Intramedullary Nails

    Zimmer is recalling ITST anti-rotation screws and femoral intramedullary nails due to unvalidated packaging operations at its Puerto Rico facility.

    Product
    ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM, 11 MM, 12 MM, 13 MM, 14 MM and 15 MM) DIA X (18, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48 and 50)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1018-2014·2014-02-26

    Zimmer Recalls Modular Austin Moore Femoral Neck Implants Due to Packaging Validation

    Zimmer is recalling Modular Austin Moore Femoral Neck implants because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001, 455503001 and 455504001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1017-2014·2014-02-26

    Zimmer Recalls Hip Prostheses Due to Packaging Validation Issues

    Zimmer, Inc. is recalling specific hip prosthesis models because packaging operations at a Puerto Rico facility were not properly validated, raising concerns about sterile barrier integrity.

    Product
    MOORE HIP PROS LONG FENES, MOORE HIP PROS NRW STR FE, MOORE HIP PROS STR FENEST, THOMPSON HIP PROSTHESIS sizes 3, 4, 5, and 6, and Mod Austin Moore Fem Stem
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1019-2014·2014-02-26

    Zimmer Recalls Bipolar Liners and Multipolar Cups Due to Packaging Validation Issues

    Zimmer is recalling 7,044,680 units of bipolar liners and multipolar cups because packaging operations at a Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    Bipolar liners and Multipolar cups with the following dimensions in MM (38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 53, 54, 55, 57, 58, 60, 64, 66, 68, 70, 72) and several OD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1015-2014·2014-02-26

    Zimmer Recalls Orthopedic Implants Due to Packaging Validation Deficiencies

    Zimmer is recalling specific orthopedic implants because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    DISTAL MEDIAL FEMORAL CON, DISTAL POSTERIOR/LATERAL, DISTAL SMALL VOLAR RADIUS, PROXIMAL DORSAL ULNA PLT, and PROXIMAL MEDIAL TIBIAL 4.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1035-2014·2014-02-26

    Zimmer Recalls Modular Hip Implants Due to Packaging Validation Issues

    Zimmer is recalling specific lots of Modular Austin Moore and Moore Hip ProS hip implants because packaging operations at a Puerto Rico facility were not properly validated.

    Product
    MODULAR AUSTIN MOORE SOLI and MOORE HIP PROS REG SOLID
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1007-2014·2014-02-26

    Zimmer Recalls M/DN R-F IM Nails Due to Packaging Validation Issues

    Zimmer is recalling M/DN R-F IM Nails because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    M/DN R-F IM NAIL 9MM DIA , 10 MM, 11 MM, 12 MM, 13 MM and 14 MM. Item codes starting with 0022400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1023-2014·2014-02-26

    Zimmer Recalls Modular Hip Cup Liners Due to Packaging Validation Issues

    Zimmer is recalling 7,044,680 modular hip cup liners because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR CUP 20 DEGREE LIN MODULAR CUP 7MM OFFSET LI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1008-2014·2014-02-26

    Zimmer Recalls Sterile Orthopedic Screws and Nails Due to Packaging Validation Issues

    Zimmer is recalling specific sterile orthopedic screws and nails because packaging operations at its Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    RECON SCREW LG 5.5MM DIA and M/DN FEM IM NAIL 8MM DIA to 16 MM DIA. Item codes starting with 0022520, 0022521, 002522, 0022523, 0022524 and 0022525.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1022-2014·2014-02-26

    Zimmer Recalls NEXGEN Knee Implant Components Due to Packaging Validation Issues

    Zimmer is recalling NEXGEN knee implant components because packaging operations at its Puerto Rico facility were not properly validated, despite passing subsequent seal integrity tests.

    Product
    NEXGEN MIS TIBIA PLATE PR NEXGEN TAPER PLUG NEXGEN PRECOAT PEG TIB PL NEXGEN MICRO ALL-POLY PAT NEXGEN ALL-POLY PATELLA, NEXGEN PRECOAT STEMMED TI NEXGEN OPTION STEMMED TIB NEXGEN STRAIGHT STEM EXT NEXGEN SHARP FLUTED STEM NEXGEN FLUTED STEM EXT, 1 NEXGEN FLU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1021-2014·2014-02-26

    Zimmer Recalls Knee Implant Components Due to Packaging Validation Issues

    Zimmer is recalling specific knee implant components because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    I/B II KNEE DOMED PATELLA, I/B II KNEE FLUTED ROD (1 and 2), MGII KNEE 10MM PATELLA (2,3 and 4), MGII KNEE SLF-TAP BONE ST
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1020-2014·2014-02-26

    Zimmer Recalls NEXGEN Osteotomy Cortical Bone Screws Due to Packaging Validation

    Zimmer is recalling NEXGEN Osteotomy Cortical Bone Screws because packaging operations at a Puerto Rico facility were not properly validated, despite passing seal integrity tests.

    Product
    NEXGEN OSTEOTOMY CORT BON. Item codes starting with 0052500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1033-2014·2014-02-26

    Zimmer Recalls 6 Degree Femoral Heads Due to Packaging Validation Issues

    Zimmer is recalling 6 Degree COCR Femoral Heads and 6 Degree Unipolar Femoral Heads because packaging operations at a Puerto Rico facility were not properly validated.

    Product
    6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0277-2014·2013-11-20

    Zimmer Recalls Hip Stems Due to Sterile Barrier Integrity Testing

    Zimmer, Inc. is recalling VerSys Hip System femoral stems because historic packaging validations indicated a need for additional testing to ensure sterile barrier integrity.

    Product
    VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Heritage Hip System Revision Femoral Stems. Indicated for total hip arthroplasty.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0129-2014·2013-11-13

    Zimmer Recalls Ti-Magna Fx Washers Due to Sterile Barrier Integrity Testing

    Zimmer, Inc. is recalling 2,632 Ti-Magna Fx Washers distributed in Japan to ensure sterile barrier integrity after a review of historic packaging validations.

    Product
    Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used with Ti-Versa-Fx¿ II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna Fx
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1981-2013·2013-08-28

    Zimmer Recalls Moore Hip Prosthesis Stems for Sterile Barrier Testing

    Zimmer is recalling 1,710 Moore Hip Prosthesis Long Fenestrated Stems to test sterile barrier integrity after a review of historic packaging validations.

    Product
    Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement.
    Category
    Medical Device
    Distribution
    Distributed nationwide