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The Anspach Effort, Inc. recalls ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otol
Recalled May 25, 2016 · FDA recall Z-1667-2016 · The Anspach Effort
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. · FDA Class II
Units
27 devices
Sold at
US Distribution in the states of KY and TX.
Description
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.
Product
ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
Manufacturer(s)
The Anspach Effort, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →