Recall Z-2306-2015 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
The Anspach Effort, Inc.
ANSPACH -4MM Carbide Fluted Ball, Extends 27MM; REF S-4BL-C-G1. Cutting shaping bone including spine and cranium.
| Date | Jul 29, 2015 (initiated Apr 13, 2015) |
| Status | Terminated |
| Reason | G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater. |
| Root cause | Device Design |
| Action | Anspach sent an Urgent Notice: Medical Device Recall (Correction) letter of Anspach G1 Dissection Tools dated May 6, 2015, to all affected customers. Customers were not required to return their inventory of GI Dissection tools. Customers were instructed to complete, sign, and return the attached reply form confirming receipt of the letter by fax or email. Customers were also instructed to forward the letter as appropriate immediately. Customers with questions should contact the Complaint Handling Unit Manager at 561-494-3673 or contact their Anspach Sales Representative. For questions reg |
| Quantity | 796 tools. |
| Distribution | Worldwide Distribution - US including AZ, CA, CO, FL, GA, IL, KY, LA, MN, MO, NC, NJ, NY, OH, OR, PA, TX, and Internationally to Canada and China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113476 | ANSPACH DISSECTION TOOLS The Anspach Effort, Inc., Dec 16, 2011 |