Recall Z-0783-2013 ยท HTT Burr, Orthopedic
The Anspach Effort, Inc.
Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.
| Date | Feb 4, 2013 (initiated Sep 5, 2012) |
| Status | Terminated |
| Reason | Contact between the bur and bur guard could generate metal fragments that may or may not be visible to the surgeon and can potentially remain in the surgical site. The materials used to fabricate the bur guard are not traceable, design validation did not effectively evaluate adequate protection of adjacent tissue and inspection results for each of these bur guards were not documented. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, Anspach Effort, Inc. sent an "URGENT: Medical Device Removal" letter dated November 7, 2012, to its customer. The letter identified the product, problem and actions to be taken. The customer was instructed to do the following: 1) Screen their inventory and remove and return all products immediately. 2) Complete and return the attached Customer Reply Form via fax or email to the address provided on the form. Should the customer have any questions, please contact Anspach Product Support at (800) 327-6887. |
| Quantity | 8 devices |
| Distribution | Distributed in the state of Massachusetts |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.