The Recall Desk

Hazard

Surgical Implant Defect recalls

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

What the numbers show

Total
6
Critical
0
Severe
1
Most recent
2025-06-04

Of the 6 surgical implant defect recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (17%) 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 implant defect 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.

1–6 of 6

  • SevereFDA (Devices)·Z-1817-2025·2025-06-04

    ELEOS Collar Stem Cemented Fluted Implant Size Mislabeling Recall

    Onkos Surgical is recalling 23 units of ELEOS Collar Stem implants (Model HC-13120-03M) because packages labeled as 13mm contained 15mm diameter implants instead, creating a risk of implant mismatch during surgery.

    Product
    ELEOS COLLAR STEM, CEMENTED, FLUTED, 13MM X 120MM. Model Number: HC-13120-03M. Component of Limb Salvage System with BioGrip.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • HighFDA (Devices)·Z-1043-2023·2023-02-08

    Biomet Vanguard Knee Implant Components Recalled for Incorrect Labeling

    Biomet, Inc. is recalling specific Vanguard Knee System prosthetic components that are incorrectly labeled with wrong sizes and sides. This labeling error could result in incorrect implant placement during knee replacement surgery.

    Product
    (1) Vanguard Knee System PS Open Box Femoral; Left; 57.5 mm. Intended for Knee joint replacement prostheses. Item Number: 183122 EXPANDED RECALL: (2) Vanguard Knee System PS Open Box Femoral; Left; 60 mm. Item Number: 183124 (3) Vanguard Knee System PS Open Box Femoral; Left;
    Category
    Medical Device
    Distribution
    6 states
  • HighFDA (Devices)·Z-0695-2023·2022-12-21

    Hip replacement surgical kits recalled by DeRoyal Industries

    DeRoyal Industries Inc has recalled 19 anterior approach total hip replacement surgical kits distributed across 23 U.S. states. This Class II recall was initiated voluntarily by the manufacturer.

    Product
    DeRoyal ANTERIOR APPROACH TOTAL HIP A&B PGYBK, REF 89-10612.01
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0899-2022·2022-04-20

    iTotal Identity Knee Replacement System—incorrect tibial base plate packaged

    Conformis is recalling specific units of the iTotal Identity Posterior Stabilised Knee Replacement System due to incorrect tibial base plate implants being packaged in surgical kits.

    Product
    iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1804-2021·2021-06-16

    Atec Insignia Anterior Cervical Plate System Recall: Potential Screw Mechanism Failure

    Alphatec Spine is recalling 7 units of the Atec Insignia Anterior Cervical Plate System because the screw blocking mechanism could disassociate or unlock during or after surgery.

    Product
    Atec Insignia Anterior Cervical Plate System, REF 136-0121, Insignia, ACP, 1-Level, 21 mm, Rx Only, Non-Sterile, UDI: (01)00190376268477
    Category
    Medical Device
    Distribution
    Distributed nationwide