The Recall Desk

Hazard

Device Failure recalls

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

What the numbers show

Total
881
Critical
30
Severe
255
Most recent
2026-09-02

Of the 881 device failure recalls we have scored against our rubric, 30 (3%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (29%) 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 device failure 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.

501–525 of 881

  • SevereFDA (Devices)·Z-2681-2018·2018-08-15

    Howmedica Recalls rHead Stem Implant 6mm Collar Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 245 rHead Stem Implant 6mm Collar units because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead 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
  • SevereFDA (Devices)·Z-2685-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Revision Rate Concerns

    Howmedica Osteonics Corp. is recalling 314 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant Plasma Coated, 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
  • 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
  • SevereFDA (Devices)·Z-2721-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 118 rHead Recon Stem Implants because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant non-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
  • SevereFDA (Devices)·Z-2717-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implants Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 133 rHead Recon Stem Implants because the revision rate is higher than other similar devices, potentially affecting post-surgery performance.

    Product
    rHead Recon Stem Implant non-coated, 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
  • SevereFDA (Devices)·Z-2686-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implant Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 303 rHead Recon Stem Implant Plasma Coated, Size 2 units because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Recon Stem Implant Plasma Coated, 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
  • SevereFDA (Devices)·Z-2712-2018·2018-08-15

    Howmedica Recalls #3 Bipolar Radial Head Implant Due to Revision Rate

    Howmedica Osteonics Corp. is recalling 999 units of the #3 Bipolar radial head implant because literature reviews indicate a higher revision rate than other similar devices.

    Product
    #3 Bipolar radial head 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-2718-2018·2018-08-15

    Howmedica Recalls Stryker rHead Radial Head Bipolar Stem Implants

    Howmedica Osteonics Corp. is recalling 673 units of #3 Bipolar stem implants used in the Stryker rHead system due to a higher-than-expected revision rate.

    Product
    #3 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-2730-2018·2018-08-15

    Howmedica Recalls rHead Radial Implant Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 162 units of rHead Radial Implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    rHead, Radial Implant 6 mm 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-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-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-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-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-2726-2018·2018-08-15

    Howmedica Recalls rHead Radial Implant Due to Higher Revision Rate

    Howmedica Osteonics Corp. is recalling 201 units of the rHead Radial Implant 6 mm Collar, Size 1, because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead, Radial Implant 6 mm 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-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-2667-2018·2018-08-15

    Howmedica Radial Head Implant Recalled Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 170 Lat Assembly Rad Stem Implants because literature reviews indicate higher revision rates than other similar devices.

    Product
    Lat Assembly, Rad Stem Implant,Collar 6mm, Size1. 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-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-2714-2018·2018-08-15

    Howmedica Recalls 169 Stryker rHead Bipolar Stem Implants

    Howmedica Osteonics Corp. is recalling 169 Stryker rHead Bipolar stem implants due to a higher-than-expected revision rate and potential performance issues.

    Product
    #1 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-2710-2018·2018-08-15

    Howmedica Recalls Radio Capitellum Broach Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 10 units of the Radio Capitellum Broach Large, Right, due to a higher-than-expected revision rate and potential performance issues.

    Product
    Radio Capitellum Broach 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-2682-2018·2018-08-15

    Howmedica Recalls rHead Stem Implant Due to Higher Revision Rates

    Howmedica Osteonics Corp. is recalling 268 units of the rHead Stem Implant 6mm Collar, Size 2, because literature reviews indicate a higher revision rate than other similar devices.

    Product
    rHead Stem Implant 6mm Collar, 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-2702-2018·2018-08-15

    Howmedica Recalls Radio Capitellum Orthopedic Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 124 Radio Capitellum, Recon Head, Size #4 orthopedic implants because the revision rate is higher than other similar devices.

    Product
    Radio Capitellum, Recon Head, 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-2688-2018·2018-08-15

    Howmedica Recalls rHead Recon Stem Implant Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 310 units of the rHead Recon Stem Implant, Size 4, because the revision rate is higher than other similar devices.

    Product
    rHead Recon 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-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-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