Device product
Anspach Carbide Cutting Burrs: 2MM Carbide Fluted Ball, Standard, 8 Flutes - part #QD8-2SB-C-8F, 4MM Carbide Fluted Ball, 10 Flutes - part # QD8-4B-C-10F 5MM Carbide Fluted Ball, 10 Flutes - part #QD8-5B-C-10F 7MM Carbide Fluted Ball, 14 Flutes - part #QD8-7B-C-14F Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
Z-0726-2014
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-0726-2014
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.