Hammer, Surgical
FDA adverse event reports and recall history for hammer, surgical (product code FZY), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 853
- Deaths
- 0
- Injuries
- 39
- Malfunctions
- 814
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
- 2013-08-01TerminatedDevice Design
S-LIFT Slap Hammer, Part Number: 11-50204, Revision A The slap hammers are used primarily to remove trial instruments that are used to estimate sizes of intervertebral body fusion devices intended to promote fusion. These devices were used in conjunction with lumbar intervertebral body fusion device intended for intervertebral body fusion of the spine of skeletally mature patients.
Malfunction of slap hammer.
- 2008-09-16TerminatedProcess control
Trauma Fixation Systems - The Slotted Mallet is an auxiliary optional instrument available with the Phoenix Tibia Nail System. If desired, it may be used to seat the nail into the medullary canal. The Phoenix Tibial Nail System is indicated for alignment, stabilization, fixation of fractures caused by trauma or disease and the fixation of long bones that have been surgically prepared for correction of deformity and arthrodesis.
Customer complaint received regarding the separation of the mallet handle during a medical procedure.
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