Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
Reported: January 22, 2014 Initiated: March 29, 2012 #Z-0715-2014
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.
Details
- Recalling Firm
- The Anspach Effort, Inc.
- Units Affected
- 492 (321 US)
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Great Britain, Australia, Switzerland, Sweden, France, Japan, Spain, Italy, Canada, and Netherlands.
- Location
- Palm Beach Gardens, FL
Frequently Asked Questions
What product was recalled? ▼
Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures. Recalled by The Anspach Effort, Inc.. Units affected: 492 (321 US).
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 22, 2014. Severity: Moderate. Recall number: Z-0715-2014.
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