FDADecember 7, 2022device

Adult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

anspach effortanspach

UPCs

00845384016410

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

FDA7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium2022-12-07
FDA7.5 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 cranium2022-12-07
FDA6.5 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 cranium2022-12-07
FDA6.5 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 cranium2022-12-07
FDAPediatric Craniotome Ref:CRANI-P-G12022-12-07
FDAAdult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium2022-12-07
FDA6.5 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 personnel2022-12-07
FDA6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium2022-12-07

Own something like this?

AllClear screens your whole list against every CPSC, FDA, USDA and NHTSA recall — and tells you the day a new one names something you own.

Start free — 200 items, no card →