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The Anspach Effort, Inc. recalls Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection
Recalled February 13, 2013 · FDA recall Z-0783-2013 · The Anspach Effort
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. · FDA Class II
Units
8 devices
Sold at
Distributed in the state of Massachusetts
Description
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.
Product
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.
Manufacturer(s)
The Anspach Effort, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →