Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. Part Number MCA Intended for u
FDA device recall Z-0749-2014 · posted 2014-01-15 · Terminated
Recall details
- Recalling firm
- The Anspach Effort, Inc.
- Reason for recall
- 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
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- HBE
- Quantity affected
- 163
- Distribution
- Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.
- Date initiated
- 2012-03-29
- Date posted
- 2014-01-15
- Date terminated
- 2015-03-11
- Location
- Palm Beach Gardens, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM (K042783) | The Anspach Effort, Inc. | 2004-12-17 |