Saw, Powered, And Accessories
FDA adverse event reports and recall history for saw, powered, and accessories (product code HAB), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 9,889
- Deaths
- 3
- Injuries
- 434
- Malfunctions
- 9,446
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
- 2015-12-21TerminatedDevice Design
Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland
The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.
- 2015-12-21TerminatedDevice Design
Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Single Trigger Handpiece. Rx only Made in Switzerland
The firm identified a malfunction which made it possible for a handpiece to start by itself when the power source is connected.
- 2014-10-31TerminatedDevice Design
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid of the box. Product Usage: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.
Non-injury complaints from Europe identified a malfunction that made it possible for a handpiece to start by itself when the power source is connected.
- 2011-07-01TerminatedProcess control
DYONICS POWER Shaver Blades, 4.5mm Long Curved Full Radius Convex, package of 3. Catalog Number: 7205336 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.
Product has insufficient weld between the shaft tube and tip, could result in the tip separating from the shaft tube during use.
- 2011-07-01TerminatedProcess control
DYONICS POWER Shaver Blades, 4.5mm Long Full Radius, package of 3 Catalog Number: 7205341 Product Usage: Smith & Nephew DYONICS Disposable Endoscopic Blades are indicated for resection of soft and osseous tissues in both large and small articular cavities.
Product has insufficient weld between the shaft tube and tip, could result in the tip separating from the shaft tube during use.
- 2008-09-19TerminatedProcess control
Biomet Stablecut Saw Blade - Reprocessed Sterile device -- Powered Saw and Accessories.
Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
- 2008-09-19TerminatedProcess control
Stryker Oscillating & Sagittal Blade - Reprocessed Sterile device -- Powered Saw and Accessories.
Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
- 2008-09-19TerminatedProcess control
Stryker Oscillating & Sagittal Blade - Reprocessed Sterile device -- Powered Saw and Accessories.
Sterility Compromised -- Ascent Healthcare Solutions cannot validate the sterilization process for a variety of Ascent Healthcare Solutions products.
- Open, ClassifiedUnder Investigation by firm
Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.
The Li-ion Battery Housing for the AR-400 DrillSaw Sports 400 System may not provide a complete seal around the battery, allowing for potential fluid ingress.
- TerminatedLabeling design
Zimmer Gender Solutions" Patellofemoral Joint Prosthesis Milling Handpiece
Complaints have been reported that the handpiece is inoperable. The investigation found that the complaints were related to the lack of preventative maintenance contrary to what is recommended in the instructions for use included with the handpiece. An inoperable device may lead to a delay in surgery
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