Z-0755-2014 Class II Terminated
FDA device recall Z-0755-2014 was initiated by The Anspach Effort, Inc. on Mar 29, 2012 and is designated Class II. 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… The recall status is terminated (terminated Mar 11, 2015). Affected quantity: 574.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 22, 2014
- Initiation Date
- Mar 29, 2012
- Termination Date
- Mar 11, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 574
Product Description
MCA5-15SD - 1.5MM 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 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
Distribution Pattern
Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.
Code Information
All lots are included in recall
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0755-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026