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.

26–36 of 36

  • 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
  • SevereFDA (Devices)·Z-2352-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead Damage

    FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage implanted leads, causing short circuits and requiring replacement.

    Product
    microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2359-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Lead Damage Risk

    FHC, Inc. is recalling Depth Stop Adapters because over-tightening the screw can damage implanted leads, requiring removal and replacement.

    Product
    microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),
    Category
    Medical Device
    Distribution
    46 states
  • SevereFDA (Devices)·Z-2351-2018·2018-07-11

    FHC Depth Stop Adapter Recalled for Potential Lead Damage

    FHC, Inc. is recalling the Depth Stop Adapter because over-tightening the screw can damage the implanted lead, requiring removal and replacement.

    Product
    microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-1196-2018·2018-04-04

    Zimmer Biomet Recalls AIM Tibial Nails Due to High Revision Rates

    Zimmer Biomet is recalling AIM Tibial Nails because the surgical revision rate exceeded acceptance criteria in a clinical analysis.

    Product
    AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 800508270 NAIL TIB DYN 08X27.0 - STERILE 800508285 NAIL TIB DYN 08X28.5 - STERILE 800508300 NAIL TIB DYN 08X30.0 - STERILE 800508315 NAIL TIB DYN 08X31.5 - STERILE
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1197-2018·2018-04-04

    Zimmer Biomet Recalls AIM Tibial Nails Due to High Revision Rates

    Zimmer Biomet is recalling AIM Tibial Nails because they failed a clinical analysis showing surgical revision rates exceeded acceptance criteria.

    Product
    AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 27.0 810508285 NAIL TIB DYN 08 X 28.5 810508300 NAIL TIB DYN 08 X 30.0 810508315 NAIL TIB DYN 08 X 31.5 810508330 NAIL TIB DYN 08 X 33.0 81
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1741-2015·2015-06-17

    Biomet Recalls Unilateral External Fixation Ankle Clamps Due to Assembly Error

    Biomet, Inc. is recalling 19 unilateral external fixation ankle clamps because they were assembled incorrectly. The defect may prevent full range of motion and cause the pin to loosen from the bone.

    Product
    Unilateral external fixation ankle clamp Product Usage: Unilateral external fixation for use treatment of bone conditions amenable to treatment by use of external fixation modality
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0143-2013·2012-10-31

    SpiraLok 6.5mm Anchors Recalled Due to Post-Operative Fracture

    DePuy Mitek is recalling 372 units of SpiraLok 6.5mm anchors because they fractured after surgery, requiring patient revision.

    Product
    SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0147-2013·2012-10-31

    DePuy Mitek Recalls SPIRALOK Bone Fixation Anchors Due to Fracture

    DePuy Mitek is recalling 66 SPIRALOK bone fixation anchors because they can fracture after surgery, requiring patients to undergo revision surgery.

    Product
    Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0140-2013·2012-10-31

    DePuy Mitek Recalls SpiraLok Anchors Due to Post-Operative Fracture

    DePuy Mitek is recalling 1,315 units of SpiraLok 5.0mm anchors because they may fracture after surgery, requiring patients to undergo revision procedures.

    Product
    SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0148-2013·2012-10-31

    DePuy Mitek Recalls Seven SpiraLok 5.0 Anchors Due to Fracture

    DePuy Mitek is recalling seven SpiraLok 5.0 anchors because they fractured after surgery, requiring patients to undergo revision procedures.

    Product
    SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
    Category
    Medical Device
    Distribution
    Distributed nationwide