Reported Jan 22, 2014 · Terminated
Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
The Anspach Effort, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: The Anspach Effort, Inc. · 4500 Riverside Drive · Palm Beach Gardens, FL · 33410-4235
Is this the product you have?
- Anspach MCA Cutting Burr, DFU Rx Only Designed for cutting and shaping delicate bone, primarily in otology procedures
- Lot codes and dates
- ALL LOTS for product code 18-0001
- Amount recalled
- 492 (321 US)
This recall covers 28 products
The agency filed one notice per product. You are reading one of them; the other 27 are below.
15 more are in the archive.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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