| Date Posted |
February 04, 2013 |
| Recall Number |
Z-0783-2013 |
| Product |
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. |
| Code Information |
Lot number: 2000930
|
Recalling Firm/
Manufacturer |
The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens, Florida 33410-4235 |
| Consumer Instructions |
Contact the recalling firm for information |
| For Additional Information Contact |
Jessica Smith
561-627-1080
|
Reason for
Recall |
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.
|
| 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 in Commerce |
8 devices |
| Distribution |
Distributed in the state of Massachusetts |
| |
|
