Z-0783-2013 Class II Terminated
FDA device recall Z-0783-2013 was initiated by The Anspach Effort, Inc. on Sep 5, 2012 and is designated Class II. 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… The recall status is terminated (terminated Aug 13, 2014). Affected quantity: 8 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 13, 2013
- Initiation Date
- Sep 5, 2012
- Termination Date
- Aug 13, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8 devices
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.
Distribution Pattern
Distributed in the state of Massachusetts
Code Information
Lot number: 2000930
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0783-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026