Reamer
FDA adverse event reports and recall history for reamer (product code HTO), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 29,392
- Deaths
- 5
- Injuries
- 1,214
- Malfunctions
- 28,132
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
- 2024-03-01Open, ClassifiedProcess control
RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects, and to remove infected and necrotic bone and tissue from the medullary canal in the treatment of osteomyelitis. Part Number: 314.746S
Products not sterilized, sterility cannot be confirmed
- 2023-02-06Open, ClassifiedProcess control
Identity Shoulder System Resection Planer 35mm Resection Planer
Two planers were found to be unusable during sawbones shoulder training.
- 2016-11-23TerminatedUnder Investigation by firm
Synthes Flexible Shaft, Orthopedic manual surgical instrument The Flexible shafts are intended for use as an optional reaming step in intramedullary nailing systems.
Non-conforming material used.
- 2016-11-19TerminatedNonconforming Material/Component
2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
- 2016-11-19TerminatedNonconforming Material/Component
3.0 mm Reaming Rod/950 mm, Sterile
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
- 2016-11-19TerminatedNonconforming Material/Component
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
- 2016-11-19TerminatedNonconforming Material/Component
2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
- 2016-11-19TerminatedNonconforming Material/Component
2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
- 2016-11-19TerminatedNonconforming Material/Component
2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
- 2016-06-06TerminatedProcess design
DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. This could potentially be reproduced during use and reprocessing.
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