Clamp, Surgical, General & Plastic Surgery
FDA adverse event reports and recall history for clamp, surgical, general & plastic surgery (product code GDJ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 299
- Deaths
- 3
- Injuries
- 41
- Malfunctions
- 250
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2025-01-16Open, ClassifiedUnder Investigation by firm
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAUS TWL CLP STER 5.25 25, Model Number 96-2636; general purpose clips
Reports of various packaging issues that may result in a breach of the sterile barrier.
- 2024-07-23Open, ClassifiedUnder Investigation by firm
TourniKwik Tourniquet Set (CFN 79012)
Incorrect component placed in four manufactured lots of the TourniKwik" Tourniquet Set.
- 2024-05-10Open, ClassifiedProcess control
Medtronic Tourniquet Sets: a) DLP 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP 7 in (17.8 cm) Tourniquet Kit, Model Number 79009
Potential for unsealed sterile packing.
- 2013-08-29TerminatedDevice Design
Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp extramedullary (EM) referencing instrument (Cat. No. 6541-2-609), for use in Total Knee Arthroplasty (TKA) when the surgeon elects to use Stryker's Triathlon Total Knee System in conjunction with EM referencing. Non-Sterile Instrument.
Cracks or fracture of the Triathlon Tibial Alignment Ankle Clamp, an instrument.
- 2005-07-07TerminatedOther
Smith & Nephew Grasper, Cupped 3.4mm REF: 011014
Cupped Grasper Handle marked incorrectly as Duckbill Upbiter
- TerminatedDevice Design
MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
- TerminatedDevice Design
MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E The MAYFIELD Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
- TerminatedDevice Design
MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
- TerminatedDevice Design
MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is necessary, positional freedom is required and where X-ray imaging modalities will be used.
There is a potential for the knob assembly in the swivel adapter to fracture/break during use.
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