Instrument, Cutting, Orthopedic
FDA adverse event reports and recall history for instrument, cutting, orthopedic (product code HTZ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,490
- Deaths
- 0
- Injuries
- 33
- Malfunctions
- 1,454
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
- 2020-02-13TerminatedProcess control
SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.
- 2015-08-05TerminatedNonconforming Material/Component
Synthes Battery Power Line II Oscillator Model 530.710, orthopedic surgical power tool.
Saw head separated from the drive unit or began to come loose.
- 2014-06-11TerminatedDevice Design
Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.
It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot.
- 2013-09-13TerminatedDevice Design
AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products are contained within the Aequalis reversed II Instrument set tray no.YKAD83 and the Aequalis reversed fracture instrument set tray no.YKAD95. The items affected are MWD21, MWD023, MWD024 and MWD025. The impactor is an instrument used during shoulder arthroplasty; it is not implanted. The impactor is used to set the glenoid sphere, poly insert, spacer, and hemi adapter into place during surgery. The impactor is a two piece instrument which consists of a tip and a handle. The tip is made of plastic and metal that is pressed together for assembly.
Following the identification of the disassociation of an impactor tip during surgery, Tornier is initiating a voluntary recall of all lots of Aequalis Reversed II and Reversed Fracture impactors. Upon review of the event, Tornier determined that a redesign of the instrument was warranted. These products are contained within the Aequalis Revered II instrument set tray no YKAD83 and the Aequalis R
- 2009-01-13TerminatedOther
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 55 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485150. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
- 2009-01-13TerminatedOther
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 57.5 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485151. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
- 2009-01-13TerminatedOther
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 60 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485152. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
- 2009-01-13TerminatedOther
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 62.5 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485153. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
- 2009-01-13TerminatedOther
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 65 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485154. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
- 2009-01-13TerminatedOther
Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 67.5 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485155. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.
Monitor instrument, cutting, orthopedic automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.