Device product
Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide Fluted ball part # S-3SB-C, 4MM Carbide Fluted ball part # S-4B-C, 4MM Carbide Fluted ball Extended 27MM part # S-4BL-C, 5MM Carbide Fluted ball part # S-5B-C, and 6MM Carbide Fluted ball part # S-6B-C. Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
Z-0727-2014
Product summary
- Event
- Event 67146
- Status
- Terminated
- Classification
- Class II
- Quantity
- 28,562 total of all products in this recall
- Official record key
device-enforcement:Z-0727-2014
Official wording
Reason: Some carbide cutting burr fractured during use.
Code information: All Lot numbers distributed within the 5 years expiration date (12/13 thru 10/18)
Distribution pattern: Worldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.
Derived failure modes
-
Unknown
Some carbide cutting burr fractured during use.