The Recall Desk

Manufacturer

Howmedica Osteonics Corp.

111 recalls in our database name Howmedica Osteonics Corp. as the manufacturing or recalling firm.

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.

76–100 of 111

  • HighFDA (Devices)·Z-0889-2024·2024-02-07

    Total Knee Replacement Component Recalled Due to Oxidation Risk

    Howmedica Osteonics Corp. is recalling SCORPIO Total Knee replacement components from specific manufacturing batches due to potential oxidation in raw materials over 5 years old. Oxidation can impact the material's properties.

    Product
    SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-0910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0926-2024·2024-02-07

    Tibial Knee Replacement Implants Recalled Due to Material Oxidation

    Howmedica Osteonics is recalling tibial bearing inserts used in knee replacements manufactured from UHMWPE raw material over 5 years old. The material may develop elevated oxidation levels that could impact its structural properties.

    Product
    TIBIAL BEARING INSERT SERIES P-S I ASSY Intended for knee replacement Product Number: 7291-0324
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0878-2024·2024-02-07

    Knee replacement implant recalled due to material oxidation risk

    Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee implants (Lot Numbers 482LM8, HH43K7) manufactured with aged UHMWPE material. The raw material is over 5 years old and may develop oxidation that could affect the implant's material properties.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0882-2024·2024-02-07

    SCORPIO TS TIB INSERT Knee Replacement Components Recalled for Potential Material Degradation

    Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee replacement inserts manufactured with aging raw material. The material may develop elevated oxidation that could affect performance.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0914-2024·2024-02-07

    Knee Replacement Inserts Recalled Due to Potential Material Degradation

    Howmedica Osteonics is recalling PRIMARY REV.TIB.INSERT-DURACON knee replacement inserts manufactured with aging UHMWPE material that has potential for oxidation affecting material properties. Affected lots: 36273601 and 36609701.

    Product
    PRIMARY REV.TIB.INSERT-DURACON Intended for knee replacement. Product Number: 6637-4-031
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0923-2024·2024-02-07

    Knee Replacement Component Recalled for Potential Material Oxidation

    Howmedica Osteonics is recalling PS Lipped Tibial Insert Assy knee replacement components manufactured with UHMWPE material older than 5 years due to potential oxidation affecting performance.

    Product
    PS LIPPED TIBIAL INSERT ASSY DURACON Intended for knee replacement Product Number: 6742-1-411
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0886-2024·2024-02-07

    Knee Replacement Component Recalled Due to Raw Material Oxidation Risk

    Howmedica Osteonics Corp. is recalling a SCORPIO TOTAL KNEE prosthesis component because UHMWPE raw material over 5 years old may have elevated oxidation levels affecting material properties and implant performance. Consumers with this implant should contact their physician for guidance.

    Product
    SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0910-2024·2024-02-07

    Knee Replacement Implant Components Recalled for Material Degradation Risk

    Howmedica Osteonics Corp. is recalling specific lots of knee replacement implant components manufactured with aged raw material. The UHMWPE material may experience oxidation that could affect its structural properties.

    Product
    LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement. Product Number: 6637-0-631
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0892-2024·2024-02-07

    Knee Replacement Component Recalled Due to Potential Material Degradation

    Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Concentric Dome Patellas manufactured with raw material over 5 years old, which may have elevated oxidation levels affecting material properties.

    Product
    SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #9 -Intended for knee replacement Part Number: 73-2910
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0891-2024·2024-02-07

    Knee Replacement Implant Component Recalled for Material Degradation Risk

    Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Concentric Dome Patella components due to potential oxidation in raw materials over 5 years old. No illnesses have been reported.

    Product
    SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0917-2024·2024-02-07

    Knee Replacement Tibial Inserts Recalled Due to Material Oxidation Risk

    Knee replacement tibial inserts from Howmedica may have elevated oxidation if manufactured with raw material over 5 years old, potentially affecting material properties.

    Product
    DURATION A-P LIPPED TIB.INSERT-DURAC Intended for knee replacement Product Number: 6642-1-911
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0869-2024·2024-02-07

    Knee replacement patella component recalled due to material oxidation risk

    Howmedica Osteonics Corp. is recalling SCORPIO RECESSED PATELLA knee replacement components manufactured from UHMWPE raw material over 5 years of age, which may develop elevated oxidation affecting material properties.

    Product
    SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0870-2024·2024-02-07

    Knee implant component recalled due to potential material oxidation

    Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee implant components made from UHMWPE material over 5 years old that may develop elevated oxidation.

    Product
    SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0872-2024·2024-02-07

    Knee replacement implant recalled for material oxidation risk

    Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee replacement components due to potential oxidation of the UHMWPE material in units manufactured with raw material over 5 years of age.

    Product
    SCORPIO RECESSED PATELLA-Intended for knee repalcment Part Number: 3044-0032
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0875-2024·2024-02-07

    Knee replacement implant recalled for potential material oxidation

    Howmedica Osteonics recalls SCORPIO TS TIB knee replacement inserts (lot TA21X9) manufactured from UHMWPE material over 5 years old due to potential elevated oxidation that could affect material properties. No injuries reported.

    Product
    SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0906-2024·2024-02-07

    Knee replacement implant insert recalled due to material degradation risk

    Howmedica Osteonics Corp. is recalling a knee replacement implant insert due to potential material oxidation. UHMWPE raw material over 5 years old may develop elevated oxidation levels, affecting implant properties.

    Product
    LEFT SMALL-PCA MOD.REV.DUR.REV.INSERT Intended for knee replacement Part Number: 6637-0-028
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1921-2023·2023-06-21

    Exeter V40 Trial Head 26mm -3 Color Mislabeling

    An orthopedic trial component may have incorrect color labeling. The Exeter V40 Trial Head (26mm, -3) may appear green when it should be blue. Two units distributed in Ireland.

    Product
    Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1654-2023·2023-06-07

    Knee Replacement Insert Mislabeled; Contents May Not Match Catalog Number

    Howmedica Osteonics Corp. is recalling TRIATHLON X3 knee replacement bearing inserts because products labeled with one catalog number may actually contain a different specification. This mislabeling could result in incorrect implant sizing during surgery.

    Product
    TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1653-2023·2023-06-07

    Knee replacement implant bearing inserts mislabeled with wrong catalog numbers

    Howmedica Osteonics recalled 24 TRIATHLON X3 tibial bearing inserts due to mislabeling, where units labeled with one catalog number may contain a different size. Medical facilities should discontinue use and contact the manufacturer.

    Product
    TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM-Intended for knee replacement Catalog Number: 5531-G-312-E
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1385-2023·2023-04-19

    Knee implant trial components recalled for incorrect size laser markings

    Stryker MAKO RESTORIS MCK tibial baseplate trial components used in knee surgery contain incorrect laser markings indicating component size. This affects 52 units distributed internationally and could lead to implantation of wrong-sized components during surgery.

    Product
    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1386-2023·2023-04-19

    Stryker MAKO RESTORIS tibial baseplate trial recalled for incorrect size marking

    Stryker is recalling 102 units of MAKO RESTORIS MultiCompartmental Knee tibial baseplate trials with incorrect size laser markings. Wrong markings could lead to selection of incorrect implant sizes during partial knee replacement surgery.

    Product
    stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0737-2023·2022-12-28

    Tobra Bone Cement Recall for Missing Turkish Instructions

    Howmedica Osteonics is recalling Tobra bone cement because packaging instructions lack Turkish language translation, though the instructions themselves are accurate. The recall affects 20 units distributed internationally.

    Product
    Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0736-2023·2022-12-28

    Bone Cement Recall: Missing Turkish Language Instructions for Use

    Howmedica Osteonics Corp. is recalling Full Dose CE Simplex P Single Bone Cement because the included instructions for use lack Turkish language translations. The product content itself is accurate; only the language translation is missing.

    Product
    Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0240-2023·2022-11-23

    Simplex HV bone cement distributed under wrong part number

    Howmedica distributed bone cement under incorrect part number 6193-1-010 instead of ordered 6195-1-010. The distribution error affected 90 units shipped nationwide.

    Product
    Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1778-2022·2022-10-05

    Incompatible tibial bearing supplied for knee prosthesis installation

    An MK4 tibial bearing knee implant component was mistakenly supplied when an MK3 model was required. The mismatch was discovered during surgery and corrected by the surgeon.

    Product
    Short tibial bearing MK4 - Std, STM, Catalog No. SMMLTB02. Knee prosthesis component.
    Category
    Medical Device
    Distribution
    0 states