THE Anspach Effort, Inc.
FDA adverse event reports naming THE Anspach Effort, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: THE ANSPACH EFFORT, INC..
- Total reports
- 3,941
- Deaths
- 0
- Injuries
- 17
- Malfunctions
- 3,909
Reports per year
Source: FDA adverse event reports by year received, 2006–2024. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Motor, Drill, ElectricHBC1,175
- Motor, Drill, PneumaticHBB1,073
- Drill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceERL715
- Instrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentHSZ322
- Drills, Burrs, Trephines & Accessories (Simple, Powered)HBE269
- Instrument, Surgical, DisposableKDC169
- Bur, Surgical, General & Plastic SurgeryGFF57
- Drills, Burrs, Trephines & Accessories (Compound, Powered)HBF50
- Motor, Surgical Instrument, Ac-PoweredGEY43
- Tray, SurgicalLRP43
Recent recalls
- 2023-01-07Open, ClassifiedUnder Investigation by firm
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
- 2023-01-07Open, ClassifiedUnder Investigation by firm
6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical personnel
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
- 2023-01-07Open, ClassifiedUnder Investigation by firm
Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
- 2023-01-07Open, ClassifiedUnder Investigation by firm
6.5 cm Adult Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
- 2023-01-07Open, ClassifiedUnder Investigation by firm
7.5 cm Large Craniotome Attachment Use with XMax, microMax, and eMax Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
- 2023-01-07Open, ClassifiedUnder Investigation by firm
Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
- 2023-01-07Open, ClassifiedUnder Investigation by firm
7.5 cm Large Rotating Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
- 2023-01-07Open, ClassifiedUnder Investigation by firm
6.5 cm Pediatric Craniotome Attachment. Use with XMax, microMax, and eMax Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
- 2023-01-07Open, ClassifiedUnder Investigation by firm
Pediatric Craniotome Ref:CRANI-P-G1
Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
- 2018-01-11TerminatedUnder Investigation by firm
OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone and soft tissue.
This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account.
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