—#124776

Product

Anspach Carbide Cutting Burrs & Drums: 2MM Carbide Fluted Ball, Extended part # S-2B-C and 7MM Carbide Fluted Ball part # S-7B-C Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium

FDA product code: HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K080802
Affected lot / code info: All Lot numbers distributed within the 5 years expiration date (12/13 thru 10/18)

Why it was recalled

Some carbide cutting burr fractured during use.

Root cause (FDA determination)

Process design

Action the firm took

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: customer.support@synthes.com. 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 customer.support@synthes.com.

Recalling firm

Firm: The Anspach Effort, Inc.
Address: 4500 Riverside Drive, Palm Beach Gardens, Florida 33410-4235

Distribution

Distribution pattern: Worldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.

Timeline

Recall initiated: 2013-12-17
Posted by FDA: 2014-01-13
Terminated: 2016-05-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124776. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.