The Recall Desk

Manufacturer

Howmedica Osteonics Corp.

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

What the numbers show

Total
248
Critical
0
Severe
18
Most recent
2026-10-21

Of the 248 recalls from Howmedica Osteonics Corp. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 18 (7%) 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.

1–25 of 248

  • ModerateFDA (Devices)·Z-0165-2027·2026-10-21

    Howmedica Recalls TS Femoral Prep Trays Due to Sterilization Instructions

    Howmedica Osteonics Corp. is recalling 582 TS Femoral Prep Trays because reprocessing instructions may lead to residual moisture after sterilization.

    Product
    TS Femoral Prep Tray, Triathlon. Catalog Number: 6543-6-507.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0166-2027·2026-10-21

    Howmedica Recalls Triathlon Hinge Femoral Prep Trays Due to Moisture Risk

    Howmedica Osteonics Corp. is recalling 359 Triathlon Hinge Femoral Prep Trays because reprocessing instructions may leave residual moisture after sterilization.

    Product
    Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0164-2027·2026-10-21

    Howmedica Recalls Triathlon Universal Baseplate Finishing Trays Due to Moisture Risk

    Howmedica Osteonics Corp. is recalling 605 Triathlon Universal Baseplate Finishing Trays because reprocessing instructions may leave residual moisture after sterilization.

    Product
    TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3201-2026·2026-09-23

    Howmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation

    Howmedica Osteonics Corp. is recalling specific orthopaedic implant components made with aged UHMWPE material. The material may oxidize, leading to increased wear and potential device failure.

    Product
    ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT 48MM 69-2248 ALL POLY CONSTRAINED INSERT 50MM 69-2850 ALL POLY CONSTRAINED INSERT 52MM 69-2852…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3196-2026·2026-09-23

    Howmedica Recalls OMNIFIT Series I Acetabular Inserts Due to Material Wear

    Howmedica Osteonics Corp. is recalling OMNIFIT Series I acetabular inserts because aged polyethylene material may cause excessive wear and device failure.

    Product
    OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3206-2026·2026-09-23

    Howmedica Recalls Scorpio Patella Implants Due to Polyethylene Wear Risk

    Howmedica is recalling specific Scorpio patella implants because aged polyethylene material may cause excessive wear, leading to device failure and potential revision surgery.

    Product
    SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3195-2026·2026-09-23

    Howmedica Recalls Aged Orthopaedic Implant Components Due to Wear Risk

    Howmedica is recalling 12,156 orthopaedic implant components made with aged polyethylene material. The aging may cause excessive wear, leading to device failure and potential need for revision surgery.

    Product
    AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3204-2026·2026-09-23

    Howmedica Recalls Trident Polyethylene Knee Inserts Due to Material Aging

    Howmedica Osteonics Corp. is recalling Trident polyethylene knee inserts because aged raw material may cause excessive wear and device failure.

    Product
    TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufactured from UHMWPE (polyethylene)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3200-2026·2026-09-23

    Howmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation

    Howmedica is recalling specific orthopaedic implant components made with aged UHMWPE material that may oxidize, potentially leading to increased wear and device failure.

    Product
    DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-800 C-M062-7-500 C-M063-2-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-000 SHOULDER - GLENOID #11 5361-6111 SHOULDER - GLENOID #5 5361-6105 SHOULDER…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3198-2026·2026-09-23

    Howmedica Recalls Triathlon Hinge Inserts Due to Material Aging

    Howmedica is recalling Triathlon hinge inserts made with aged polyethylene that may wear excessively, potentially causing device fracture or the need for revision surgery.

    Product
    TRIATHLON HINGE INSERT SIZE 4 11MM 5612-P-411 TRIATHLON HINGE INSERT SIZE 4 13MM 5612-P-413 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3197-2026·2026-09-23

    Howmedica Recalls Orthopaedic Implants Due to Aged Polyethylene Material

    Howmedica Osteonics Corp. is recalling specific orthopaedic implant components manufactured with aged polyethylene material that may oxidize and increase wear.

    Product
    ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SCORPIO INSET PATELLA 73-2610 SCORPIO M-DOME PATELLA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3202-2026·2026-09-23

    Howmedica Recalls Orthopaedic Implant Components Due to Material Aging

    Howmedica Osteonics Corp. is recalling specific orthopaedic implant components made from aged polyethylene. The material may oxidize and wear excessively, potentially causing device failure.

    Product
    BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA STEM C-M113-5-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-800 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3205-2026·2026-09-23

    Howmedica Recalls Orthopaedic Implants Due to Polyethylene Material Aging

    Howmedica Osteonics Corp. is recalling specific orthopaedic implant components because aged polyethylene material may cause increased wear and device failure.

    Product
    SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-4322 SYSTEM ONE BIPOLAR 44MM 6074-4422 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3199-2026·2026-09-23

    Howmedica Recalls Orthopaedic Implants Due to Aged Polyethylene Material

    Howmedica Osteonics Corp. is recalling specific orthopaedic implant components made with aged UHMWPE material. The material may oxidize, leading to increased wear, device fracture, or the need for revision surgery.

    Product
    ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD C-M071-8-400 BEARING AND AXLE BUSHING ASSY STANDARD ELBOW…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3203-2026·2026-09-23

    Howmedica Recalls Scorpio Receded Metal Backed Patella Implants

    Howmedica Osteonics Corp. is recalling specific Scorpio knee implant components due to aged polyethylene material that may cause increased wear and potential device failure.

    Product
    SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2461-2026·2026-06-24

    Stryker Triathlon size 3 baseplate packaging contained a size 4 implant

    Triathlon Universal Baseplate Size 3 packaging is being recalled after Stryker identified that it contained a Size 4 baseplate, and vice versa. Seven units are affected.

    Product
    TRI TS BASEPLATE SIZE 3. Part Number: 5521-B-300.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2462-2026·2026-06-24

    Stryker Triathlon size 4 baseplate packaging contained a size 3 implant

    Triathlon Universal Baseplate Size 4 packaging is being recalled after Stryker identified that it contained a Size 3 baseplate, and vice versa. Seven units are affected.

    Product
    TRI TS BASEPLATE SIZE 4. Part Number: 5521-B-400.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1572-2026·2026-03-25

    Stryker sagittal saw attachment cover screws may loosen and detach

    Howmedica Osteonics is recalling the MICS3 Angled Sagittal Saw Attachment because the external screws securing the cover to the saw housing may loosen and detach during use.

    Product
    MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0963-2026·2025-12-31

    Cranial tracker devices recalled over an error message preventing use

    Howmedica Osteonics is recalling 320 Stryker CranialMask Trackers because activating the device during surgery produces an error message that makes the device unusable.

    Product
    The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2640-2025·2025-10-08

    Hip stems recalled over potential mix of two catalog numbers in packaging

    Howmedica Osteonics is recalling 55 Exeter V40 hip stems because packages labeled for one catalog number may contain the other size, and patient labels may also be affected.

    Product
    1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0023-2025·2024-10-16

    Knee Replacement Implant Recalled for Out-of-Spec Locking Tabs

    The FDA is recalling the Triathlon Universal TS Baseplate Size 2 knee implant due to defective locking tabs that may not properly engage with the tibial insert, potentially causing implant failure.

    Product
    Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and revision Total Knee Arthroplasty (TKA) when the Triathlon Knee System is selected for use. Catalog Number: 5521-B-200
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0044-2025·2024-10-16

    MAKO Integrated Cutting System Handpiece Recalled for Characterization Process Error

    Howmedica Osteonics Corp. is recalling 897 MAKO Integrated Cutting System (MICS) Handpieces worldwide due to a manufacturing characterization process error that resulted in incorrect constant values being assigned to affected units.

    Product
    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2732-2024·2024-09-04

    Custom Orthopedic Surgical Implant Does Not Match Design Specifications

    A custom-made orthopedic surgical implant was supplied for a surgical procedure that did not match the design specifications. This mismatch could affect the proper fit and function of the device during surgery.

    Product
    Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2372-2024·2024-07-24

    UNITRAX Hip Endoprosthesis Head Components Mislabeled with Incorrect Package Sizes

    Howmedica Osteonics Corp. is recalling UNITRAX Endoprosthesis Head Components because the package label size may not match the actual device inside. Mislabeling could result in the wrong implant size being used during hip surgery.

    Product
    UNITRAX Endoprosthesis Head Component - 38mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-038
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Howmedica Osteonics Corporation

Source: Wikidata (Q127687850), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.