Recall Z-1377-2013 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
The Anspach Effort, Inc.
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
| Date | May 24, 2013 (initiated Mar 4, 2011) |
| Status | Terminated |
| Reason | Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr. |
| Root cause | Labeling mix-ups |
| Action | 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. |
| Quantity | 1,827 burrs |
| Distribution | 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 Netherla |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113476 | ANSPACH DISSECTION TOOLS The Anspach Effort, Inc., Dec 16, 2011 |