Reported Feb 13, 2013 · Terminated
Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection…
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 Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.
- Lot codes and dates
- Lot number2000930
- Amount recalled
- 8 devices
Where it was sold
Why it was recalled
Contact between the bur and bur guard could generate metal fragments that may or may not be visible to the surgeon and can potentially remain in the surgical site. The materials used to fabricate the bur guard are not traceable, design validation did not effectively evaluate adequate protection of adjacent tissue and inspection results for each of these bur guards were not documented.
This product could cause temporary or reversible health problems — stop using it.
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