FDAFDA · Food and drugs·Recall number Z-0783-2013
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.
Published February 13, 2013 · Recall initiated: September 5, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Anspach Effort, Inc.
- Distributor
- Distributed in the state of Massachusetts
- Lot
- Lot number: 2000930
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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