PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: January 22, 2014 Initiated: December 17, 2013 #Z-0726-2014

Product Description

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

Reason for Recall

Some carbide cutting burr fractured during use.

Details

Recalling Firm
The Anspach Effort, Inc.
Units Affected
28,562 total of all products in this recall
Distribution
Worldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.
Location
Palm Beach Gardens, FL

Frequently Asked Questions

What product was recalled?
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. Recalled by The Anspach Effort, Inc.. Units affected: 28,562 total of all products in this recall.
Why was this product recalled?
Some carbide cutting burr fractured during use.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 22, 2014. Severity: Moderate. Recall number: Z-0726-2014.