FDADecember 7, 2022device
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
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
00845384001737
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
- FDAAdult Craniotome Ref: CRANI-A-G1 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 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 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
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