FDAOctober 6, 2016device
System Console, Single Port, with irrigation Product Usage: Electric system
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Supplied Directions for Use (DFU) did not contain a recommended service interval.
What to do
FDA enforcement status: Terminated
Brands named
anspach effortanspach
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- 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
- 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
- FDAAdult Craniotome Ref: CRANI-A-G1 Intended for cutting and shaping bone including the spine and cranium2022-12-07
- FDAPediatric Craniotome Ref:CRANI-P-G12022-12-07
- 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
- 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
- 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
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 →