Instrument, Surgical, Non-Powered
FDA adverse event reports and recall history for instrument, surgical, non-powered (product code HAO), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 352
- Deaths
- 0
- Injuries
- 36
- Malfunctions
- 305
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
- 2011-06-29TerminatedDevice Design
Sequoia final driver closure top retention, non-sterile, REF 3384-2, Zimmer Spine, Austin, Texas, The device is used to apply final torque to closure tops of the implant. The Sequoia Final Driver is used in conjunction with a counter torque tube to apply final torque to closure tops that secure the rod component to the screw head component until the torque limiting handle pops once, indicating the implant has been locked. This process is repeated with all closure tops in a construct (assembly). The Sequoia Final Driver is also used to tighten the set screw feature and lateral locking cams on the SpeedLinkII transverse connectors when used and is used to remove previously inserted closure tops during construct removal.
A rounded or partially rounded tip on the screwdriver may not provide the required locking torque to lock the closure top to the polyaxial screw. When the hex tip of the screwdriver is not fully engaged and/or the screwdriver is used off axis, the hex tip of the screwdriver can become rounded or partially rounded.
- 2010-09-22TerminatedProcess design
Integra NeuroSciences Implants, NeuroBalloon Catheter, Sterile/EO, Rx only, single use, latex free: Catalog Number 7CBD10
Certain NeuroBalloon Catheters have the potential to improperly inflate or deflate under certain conditions.
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