Recall Z-0759-2014 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
The Anspach Effort, Inc.
MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
| Date | Jan 15, 2014 (initiated Mar 29, 2012) |
| Status | Terminated |
| Reason | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decide |
| Root cause | Labeling Change Control |
| Action | Firm is performing a Medical Device Recall by sending customers a recall letter and requesting the return of Anspach Micro Curved Attachments and Dissection Tools currently on hand. |
| Quantity | 6439 total |
| Distribution | Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA. |
| 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 |