The Recall Desk

Hazard

Device Underperformance recalls

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

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2018-08-15

Of the 4 device underperformance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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 underperformance 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.

1–4 of 4

  • HighFDA (Devices)·Z-2696-2018·2018-08-15

    Howmedica Recalls Radio Capitellum Small Orthopedic Implants Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 121 Radio Capitellum Small, Right orthopedic implants because literature reviews indicate a higher revision rate than expected.

    Product
    Radio Capitellum Small, 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-2694-2018·2018-08-15

    Howmedica Recalls Radio Capitellum Small Orthopedic Implants Due to Revision Rates

    Howmedica Osteonics Corp. is recalling 214 Radio Capitellum Small, Left orthopedic implants because literature reviews indicate higher revision rates than similar devices.

    Product
    Radio Capitellum Small, Left. 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-2676-2018·2018-08-15

    Howmedica Recalls Stryker Radial Head Implant Assemblies Due to Performance Concerns

    Howmedica Osteonics Corp. is recalling 81 units of Stryker rHead Radial Head Implant Assemblies because literature indicates higher revision rates than similar devices.

    Product
    Lateral Assembly, Radial Head Impl Assembly, 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
  • ModerateFDA (Devices)·Z-1518-2013·2013-06-19

    American Optisurgical Recalls TX1 Tissue Removal System Handpieces

    American Optisurgical is recalling TX1 Tissue Removal System disposable handpieces because they were distributed without a cleared FDA 510(k) for recent product changes.

    Product
    TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery…
    Category
    Medical Device
    Distribution
    Distributed nationwide