Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Anspach Effort Recalled by The Anspach Effort, Inc. Due to Contact between the bur and bur guard could...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact The Anspach Effort, Inc. directly.
Affected Products
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.
Quantity: 8 devices
Why Was This 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.
Where Was This Sold?
Distributed in the state of Massachusetts
About The Anspach Effort, Inc.
The Anspach Effort, Inc. has 261 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report