Z-0715-2014 Class II Terminated
FDA device recall Z-0715-2014 was initiated by The Anspach Effort, Inc. on Mar 29, 2012 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Oct 12, 2017). Affected quantity: 492 (321 US).
Recall Details
- Product Type
- Devices
- Report Date
- Jan 22, 2014
- Initiation Date
- Mar 29, 2012
- Termination Date
- Oct 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 492 (321 US)
Product Description
Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to Great Britain, Australia, Switzerland, Sweden, France, Japan, Spain, Italy, Canada, and Netherlands.
Code Information
ALL LOTS for product code 18-0001
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0715-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026