Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/Attachment
FDA adverse event reports and recall history for instrument, surgical, orthopedic, pneumatic powered & accessory/attachment (product code HSZ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,087
- Deaths
- 0
- Injuries
- 41
- Malfunctions
- 1,033
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
1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & accessory/attachment Part Number: 310.15S
Products not sterilized, sterility cannot be confirmed
- 2024-03-01Open, ClassifiedProcess control
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
Products not sterilized, sterility cannot be confirmed
- 2014-07-03TerminatedProcess control
Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.
Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device.
- 2014-01-09TerminatedComponent design/selection
***REF BLACKMAX-N***Swivel/Angle Motor Assembly***Rx Only***The Anspach Effort, Inc. Intended for cutting and shaping bone.
The firm Anspach Effort of Palm Beach Gardens, FL initiated a voluntary removal of the Pneumatic Drill System, including the motor hand-piece, Auto Lube foot control, without a pressure relief valve (PRV) due to the hand piece's outer hose can rupture without warning if the air flow is blocked during use..
- 2013-11-13TerminatedLabeling Change Control
Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneumatic Motor Systems including: MicroMax Motor Systems, XMax Motor Systems, EMax2 Motor Systems, and Emax2Plus Motor Systems, all models and serial numbers. Product Usage: Indication for use is cutting and shaping bone
Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling for its Pneumatic Systems Operating Manual, Cutting Burr Chart and Product Catalog due to a recent review of their regulations and compliance requirements that determined the claim that the device is capable of dissection of biometals, bioplastics and cement has been verified, but is is not part of th
- TerminatedUnder Investigation by firm
BLACKMAX-NEURO LOW PRESSURE Product Usage: Pneumatic system
Supplied Directions for Use (DFU) did not contain a recommended service interval.
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