Device 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.
Z-1667-2016
Product summary
- Event
- Event 73738
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27 devices
- Official record key
device-enforcement:Z-1667-2016
Official wording
Reason: 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.
Code information: Model/Catalog #:OCM7-15SD, 1.5 MM Diamond Ball, Lot Numbers: J473111704 and J473111705
Distribution pattern: US Distribution in the states of KY and TX.
Derived failure modes
-
Unknown
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.