Recall Z-0715-2014 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
The Anspach Effort, Inc.
Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
| Date | Jan 10, 2014 (initiated Mar 29, 2012) |
| Status | Terminated |
| Reason | Current directions for use for the MCA cutting burs (item 18-0001) do not provide enough details regarding the intended use specifically for the MCA burrs. |
| Root cause | Error in labeling |
| Action | Anspach sent an Urgent Medical Device Labeling Correction letter dated Marach 29,, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to include the item 18-0079 with their inventory immediately, complete the attached reply form indicating their receipt of the letter. Return the completed form by fax to the number or email provided on the form. If product was further distributed to other facilities, the correction letter should be forwarded to them. Customers with quesitons should call 1-80 |
| Quantity | 492 (321 US) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Great Britain, Australia, Switzerland, Sweden, France, Japan, Spain, Italy, Canada, and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042783 | ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM The Anspach Effort, Inc., Dec 17, 2004 |