Washer, Bolt Nut
FDA adverse event reports and recall history for washer, bolt nut (product code HTN), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,480
- Deaths
- 2
- Injuries
- 700
- Malfunctions
- 755
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
- 2023-02-07Open, ClassifiedUnder Investigation by firm
RipCord Syndesmosis Button, REF: STA001K
Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.
- 2013-11-26TerminatedFinished device change control
Synthes Spiked Washers 13.5/6.5 Spiked Washers 13.5/6.5 are intended to be used in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.
During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.
- TerminatedPackaging change control
cable button for NCB Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- TerminatedPackaging process control
Arthrex Suture Washer
The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.
Monitor washer, bolt nut automatically
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