Recall Z-1574-2014 ยท HTT Burr, Orthopedic
The Anspach Effort, Inc.
ANSPACH Cutting bur, 3 mm Diamond Ball, Standard Length. REF L-3SD Use with LONG Attachments. Used for cutting and shaping bone, including the spine and cranium.
| Date | May 9, 2014 (initiated Jan 8, 2014) |
| Status | Terminated |
| Reason | Anspach product code L-3SD contained product code S-3SD which is shorter in length than the labeled product. |
| Root cause | Labeling mix-ups |
| Action | Anspach sent an "URGENT: MEDICAL DEVICE REMOVAL" letter dated January 13, 2014, to all affected customers. The letter described the product, the problem and actions to be taken. If they have distributed any of the products to other services or facilities, customers were instructed to please forward this information as appropriate. Customers with questions you contact Anspach Customer Support at (800) 327-6887, option 3 or email customer.support@synthes.com.. Customers were asked to complete the attached reply form confirm receipt of the letter, return the completed form by fax to 800-327-6661 |
| Quantity | 30 cutting burs affected |
| Distribution | Nationwide Distribution including FL, TX, NC, IL, CO, and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011444 | ANSPACH EMAX DRILL SYSTEM The Anspach Effort, Inc., Aug 8, 2001 |