—#117275

Product

***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.

FDA product code: HBE — Drills, Burrs, Trephines & Accessories (Simple, Powered)
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K113476
Affected lot / code info: Lots numbers: D433040800, D403040236, D383039472.

Why it was recalled

Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

Anspach sent an URGENT: Medical Device Correction letter dated March 4, 2011 to its customers identifying the affected product and actions to be taken by the customers. Customers questions or concerns should be directed to Anspach Customer Support at (800) 327-6887.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution-USA (nationwide) including DC and the states of OH, TX, IL, CA, GA, KY, FL, WI, NC, VA, WI, MN, MD, KS, OK, PA, OR ,HI, AZ, WA, TN, AR, IA, MI, CO, LA, NJ, IN, WV, MO, AL, NY, VT, and SC and the countries of France, Canada, Great Britain, Mexico, Australia, Sweden and Netherlands.

Timeline

Recall initiated: 2011-03-04
Posted by FDA: 2013-05-24
Terminated: 2013-12-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #117275. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.