FDA-Device2014-01-22Class II
Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
The Anspach Effort, Inc.
Hazard
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.
Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Great Britain, Australia, Switzerland, Sweden, France, Japan, Spain, Italy, Canada, and Netherlands.
Affected count
492 (321 US)
Manufactured in
4500 Riverside Drive, Palm Beach Gardens, FL, United States
Products
Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0715-2014Don't want to check this manually?
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