Device product
Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
Z-0715-2014
Product summary
- Event
- Event 67177
- Status
- Terminated
- Classification
- Class II
- Quantity
- 492 (321 US)
- Official record key
device-enforcement:Z-0715-2014
Official wording
Reason: Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs.
Code information: ALL LOTS for product code 18-0001
Distribution pattern: Worldwide Distribution - USA (nationwide) and Internationally to Great Britain, Australia, Switzerland, Sweden, France, Japan, Spain, Italy, Canada, and Netherlands.
Derived failure modes
-
Unknown
Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs.