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
FDA Recall Z-0726-2014 · Posted 2014-01-13
Advertisement
Recalling FirmThe Anspach Effort, Inc.
Recall StatusTerminated
Product CodeHBE
Date Initiated2013-12-17
Date Terminated2016-05-09
Product Quantity28,562 total of all products in this recall
Reason for Recall
Some carbide cutting burr fractured during use.
Firm Action
The firm, Anspach, sent an "URGENT: MEDICAL DEVICE REMOVAL" letter dated December 19, 2013 to their costumers. The letter described the product, problem and actions to be taken. The customers were instructed to complete the attached reply form confirming your receipt of this letter and return the completed form by Fax to: 1-800-327-6661 or Email: [email protected]. Reference RMA 200059216 when returning any devices. If you distribute(d any of the products to other services or facilities, please forward this information as appropriate .
Should you have any queries please do not hesitate to contact Anspach Customer Support at 800-327-6887 or e-mail at [email protected].
Root Cause
Process design
Distribution Pattern
Worldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement