FDA-Device2016-05-25Class II
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.
The Anspach Effort, Inc.
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.
Sold states
US Distribution in the states of KY and TX.
Affected count
27 devices
Manufactured in
4500 Riverside Dr, N/A, Palm Beach Gardens, FL, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1668-2016Don't want to check this manually?
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