The Recall Desk

Hazard

Surgical Revision recalls

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

What the numbers show

Total
36
Critical
0
Severe
9
Most recent
2026-08-12

Of the 36 surgical revision recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (25%) 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 surgical revision 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 36

  • HighFDA (Devices)·Z-2904-2026·2026-08-12

    Tissium COAPTIUM CONNECT Nerve Repair Device Shelf Life Recall

    Tissium SA is recalling the COAPTIUM CONNECT peripheral nerve repair device because the labeled 36-month shelf life is not supported by real-time data; the validated shelf life is 26 months.

    Product
    Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2675-2018·2018-08-15

    Howmedica Recalls Stryker Radial Head Implant Assemblies Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 191 Stryker rHead Radial Head implant assemblies because literature reviews indicate a higher revision rate than other similar devices.

    Product
    Lateral Assembly, Radial Head Impl Assembly, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2725-2018·2018-08-15

    Howmedica Recalls Radial Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 256 radial stem implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    radial stem implant #1 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2663-2018·2018-08-15

    Stryker rHead Radial Implant Recalled Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 211 Stryker rHead Radial Implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    Lateral Assembly, Radial Implant, Size 1 Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2689-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implant Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 265 rHead Recon Stem Implant 6mm Collar, Size 1 units because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant 6mm Collar,Size 1. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2699-2018·2018-08-15

    Howmedica Recalls Radial Head Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 107 Radial Head Assy Size #4 implants because literature review indicates higher revision rates than other devices.

    Product
    Radial Head Assy Size #4, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2680-2018·2018-08-15

    Howmedica Recalls rHead Stem Implant Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 301 rHead Stem Implant Plasma Coated, Size 4 units because literature reviews indicate higher revision rates than other similar devices.

    Product
    rHead Stem Implant Plasma Coated, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2706-2018·2018-08-15

    Howmedica Recalls rHead Standard Extended Stem Orthopedic Implants

    Howmedica Osteonics Corp. is recalling 36 units of rHead Standard Extended Stem implants due to a higher-than-expected revision rate and potential performance issues.

    Product
    rHead Standard Extended Stem, 6mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2709-2018·2018-08-15

    Howmedica Recalls rHead Recon Extended Stem Orthopedic Implants

    Howmedica Osteonics Corp. is recalling 19 rHead Recon Extended Stem Size 3 orthopedic implants due to a higher-than-expected revision rate.

    Product
    rHead Recon Extended Stem Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2719-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 141 rHead Recon Stem Implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    rHead Recon Stem Implant non-coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2697-2018·2018-08-15

    Howmedica Recalls Radial Head Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 128 Radial Head Assembly Size #2 implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    Radial Head Assy Size #2, Rad. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2679-2018·2018-08-15

    Howmedica Recalls rHead Stem Implant Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 320 rHead Stem Implant Plasma Coated, Size 3 units because literature reviews indicate higher revision rates than other similar devices.

    Product
    rHead Stem Implant Plasma Coated, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2728-2018·2018-08-15

    Howmedica Recalls 180 Radial Stem Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 180 sterile-packed radial stem implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    radial stem implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2720-2018·2018-08-15

    Howmedica Recalls 387 Stryker rHead Bipolar Stem Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 387 units of the #4 Bipolar stem implant from the Stryker rHead system because literature reviews indicate a higher revision rate than other similar devices.

    Product
    #4 Bipolar stem implant (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2700-2018·2018-08-15

    Howmedica Recalls 163 Orthopedic Radial Head Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 163 Radio Capitellum, Recon Head implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    Radio Capitellum, Recon Head, Size #2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2722-2018·2018-08-15

    Howmedica Recalls Stryker Radial Head Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 607 Stryker rHead Radial Head implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    radial head implant #2 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2691-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implant Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 298 units of the rHead Recon Stem Implant 6mm Collar, Size 3, because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2701-2018·2018-08-15

    Howmedica Recalls Radio Capitellum Orthopedic Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 225 Radio Capitellum, Recon Head, Size #3 orthopedic implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    Radio Capitellum, Recon Head, Size #3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2672-2018·2018-08-15

    Howmedica Recalls Radial Head Implant Due to Higher Revision Rate

    Howmedica Osteonics Corp. is recalling 690 Lateral Assembly, Radial Head Implant, Size 3 units because literature indicates a higher revision rate than other similar devices.

    Product
    Lateral Assembly, Radial Head Implant, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2668-2018·2018-08-15

    Howmedica Radial Head Implant Recalled Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 190 units of Lat Assembly, Rad Stem Implant, Collar 6mm, Size 2. The recall is due to higher revision rates identified in literature.

    Product
    Lat Assembly, Rad Stem Implant,Collar 6mm,Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2731-2018·2018-08-15

    Howmedica Recalls Radial Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 431 radial stem implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    radial stem implant #4 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2705-2018·2018-08-15

    Howmedica Recalls rHead Radial Head Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 45 rHead Standard Extended Stem implants because literature suggests a higher revision rate than other similar devices.

    Product
    rHead Standard Extended Stem, 6mm Collar, Size 3. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2729-2018·2018-08-15

    Howmedica Recalls Radial Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 750 radial stem implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    radial stem implant #3 (Sterile packed). Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2695-2018·2018-08-15

    Howmedica Recalls 158 Radio Capitellum Orthopedic Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 158 Radio Capitellum Large, Right orthopedic implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    Radio Capitellum Large, Right. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2664-2018·2018-08-15

    Stryker Radial Stem Implant Recalled Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 396 Stryker rHead Radial Stem Implants, Size 2, because literature reviews indicate a higher revision rate than other similar devices.

    Product
    Lateral Assembly, Radial Stem Implant, Size 2. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.
    Category
    Medical Device
    Distribution
    Distributed nationwide