FDAMarch 28, 2016device
ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 2.0 MM, Part # OCM7-2SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.
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
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