FDA Device recall Z-0759-2014
MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall
- FDA Device
- Class II
- terminated
- Published 2014-01-22
On 2014-01-22 the FDA classified a Class II recall of MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall by The Anspach Effort, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0759-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-03-29 |
| Published | 2014-01-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | The Anspach Effort |
| Distribution | US |
Product
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.
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
Identifiers
| code_info | All lots are included in recall |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0759-2014%22
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