The Recall Desk

Hazard

Revision Risk 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
0
Most recent
2023-06-07

Of the 6 revision risk 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 revision risk 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

  • HighFDA (Devices)·Z-1673-2023·2023-06-07

    Smith & Nephew ENGAGE Knee System Recalled for Elevated Revision Risk

    Smith & Nephew's ENGAGE Cementless Partial Knee System is being recalled due to higher-than-expected revision rates compared to similar devices. The recall affects 7,531 units distributed nationwide.

    Product
    Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM; b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM; c) REF 1-10013-111, SIZE 1-LEFT MED, 11MM; d) REF 1-10013-113, SIZE 1-LEFT MED, 13MM; e) REF 1-1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1671-2023·2023-06-07

    Smith & Nephew Knee Prosthesis Recalled Due to Higher-Than-Expected Revision Rate

    Smith & Nephew is recalling 1,596 units of its ENGAGE Cementless Partial Knee System due to complaint data indicating higher revision rates than comparable devices. Patients should consult their surgeon.

    Product
    Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee prothesis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1544-2023·2023-05-10

    Knee Implant Component Recalled for Surgical Positioning and Cementing Guidance

    FDA is updating surgical instructions for the LINK SLED Knee System to address early aseptic loosening and increased wear from suboptimal positioning or inadequate cementing technique. Updated training aims to prevent implant failure and unexpected revision surgery.

    Product
    LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1539-2023·2023-05-10

    Orthopedic knee implant system recalled due to early loosening risk

    Linkbio Corp. is recalling 5 units of the LINK SLED Knee System due to risk of early aseptic loosening or increased wear that could require earlier surgical revision. The recall addresses training and surgical technique to prevent implant failure.

    Product
    LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0466-2023·2022-12-21

    NexGen Stemmed Tibial Component Recalled Due to Higher Revision Rates

    Zimmer is recalling NexGen Option Stemmed Tibial Components due to higher revision rates when used with certain femoral components in knee replacements.

    Product
    NexGen Option Stemmed Tibial Component Size 3, Item Number 00-5986-037-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0467-2023·2022-12-21

    NexGen Option Stemmed Tibial Knee Component Recalled for Higher Revision Rates

    Zimmer Biomet is recalling NexGen Option Stemmed Tibial knee components (2,092 units) due to clinically significant higher revision rates when used with specific femoral components. The voluntary recall prevents future implantation with these problematic combinations.

    Product
    NexGen Option Stemmed Tibial Component Size 4, Item Number 00-5986-037-02
    Category
    Medical Device
    Distribution
    Distributed nationwide