Recall Z-0783-2013— The Anspach Effort, Inc.
Class II · Terminated
Class II FDA medical device recall by The Anspach Effort, Inc., initiated 2012-09-05, terminated 2014-08-13. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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..
- Recalling firm
- The Anspach Effort, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-05
- Terminated
- 2014-08-13
- Firm location
- Palm Beach Gardens, FL, United States
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.