The Recall Desk

Hazard

Revision Surgery recalls

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

What the numbers show

Total
163
Critical
0
Severe
83
Most recent
2026-09-23

Of the 163 revision surgery recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 83 (51%) 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 revision surgery 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.

1–25 of 163

  • 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-3178-2026·2026-09-23

    restor3d Recalls Kinos Axiom Total Ankle Systems with Incorrect Cutting Guides

    restor3d Inc. is recalling two Kinos Axiom Total Ankle Systems because they were packaged with incorrect patient-specific cutting guides, which may lead to surgical complications.

    Product
    Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
    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-2902-2026·2026-08-12

    Peripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life

    Tissium SA is relabeling COAPTIUM CONNECT nerve repair devices because the 36-month shelf life is not supported by real-time data. The revised shelf life is 26 months.

    Product
    Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2907-2026·2026-08-12

    Coaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life

    Tissium SA is relabeling Coaptium Connect nerve repair devices because the current 36-month shelf life is not supported by real-time data. The shelf life is being reduced to 26 months.

    Product
    Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2515-2026·2026-06-24

    Inspire respiratory sensing leads labeled with Use By dates beyond shelf life

    Inspire Respiratory Sensing Leads, model 4340, are being recalled because they carry an incorrect Use By Date extending beyond the validated three-year shelf life. 50 units affected.

    Product
    Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire¿ Respiratory Sensing Lead (Model 4340) is designed to detect respiratory effort. The lead features a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2456-2026·2026-06-24

    TRIGEN proximal humeral nails are missing their distal holes

    TRIGEN Proximal Straight Humeral Nails 8/7 x 16 are being recalled because a manufacturing error left them missing distal holes. Five units are affected.

    Product
    TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2516-2026·2026-06-24

    Inspire stimulation leads labeled with Use By dates beyond shelf life

    Inspire Stimulation Leads, model 4063, are being recalled because they carry an incorrect Use By Date extending beyond the validated three-year shelf life. 10 units affected.

    Product
    Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire¿ Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1523-2026·2026-03-18

    Link Endo-Model plateau 15-0027/16 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-0027/16 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-0027/16;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1520-2026·2026-03-18

    Link Endo-Model plateau 15-8521/15 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-8521/15 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-8521/15;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1512-2026·2026-03-18

    Link Endo-Model plateau 15-0027/15 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-0027/15 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-0027/15;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1522-2026·2026-03-18

    Link Endo-Model plateau 15-0027/12 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-0027/12 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-0027/12;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1516-2026·2026-03-18

    Link Endo-Model plateau 15-2836/11 recalled over screw bushing fracture

    Waldemar Link is recalling Endo-Model Replacement Plateau item 15-2836/11 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model Replacement Plateau; Item Number: 15-2836/11;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1511-2026·2026-03-18

    Link Endo-Model SL component 16-2840/05 recalled over bushing fracture

    Waldemar Link is recalling Endo-Model SL Connection Component item 16-2840/05 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1513-2026·2026-03-18

    Link Endo-Model SL component 16-2840/02 recalled over bushing fracture

    Waldemar Link is recalling Endo-Model SL Connection Component item 16-2840/02 because the bushing on a plateau screw could detach from the screw shaft due to a longitudinal fracture.

    Product
    Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
    Category
    Medical Device
    Distribution
    Distributed nationwide