The Recall Desk

Hazard

Screw Back Out recalls

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

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2017-12-27

Of the 3 screw back out 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 screw back out 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.

1–3 of 3

  • HighFDA (Devices)·Z-0266-2018·2017-12-27

    Medacta Recalls GMK Knee System Inserts Due to Screw Back-Out Risk

    Medacta is recalling 12,768 GMK knee system inserts nationwide due to a reported 0.1% occurrence rate of post-operative screw back-out.

    Product
    The GMK knee system: designed for cemented use in total knee arthroplasty. Sphere and Primary Inserts with part number ranges: 02.12.0110FL - 02.12.0620FL; 02.12.0110FR - 02.12.0620FR; 02.07.0110PSF - 02.07.0620PSF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0450-2016·2015-12-30

    Biomet Recalls A.L.P.S. 4.0mm Cancellous Locking Screws Due to Thread Defect

    Biomet is recalling A.L.P.S. 4.0mm Cancellous Locking Screws because a single-lead thread design may cause screws to sit proud or back out, potentially requiring revision surgery.

    Product
    A.L.P.S. 4.0mm Cancellous Locking Screws intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones.
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-0455-2014·2013-12-11

    Synthes Zero-P VA Implant Recalled for Potential Screw Back-Out Risk

    Synthes USA is recalling specific Zero-P VA implants because a screw could back out if the blocking mechanism is not visually confirmed to cover the screw head.

    Product
    Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P VA Implant 7 MM Height Parallel Sterile is a stand alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying r
    Category
    Medical Device
    Distribution
    Distributed nationwide