FDA Device recall Z-0783-2013
Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard
- FDA Device
- Class II
- terminated
- Published 2013-02-13
On 2013-02-13 the FDA classified a Class II recall of Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard by The Anspach Effort, citing 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 u….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0783-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-05 |
| Published | 2013-02-13 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | The Anspach Effort |
| Distribution | MA |
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.
Identifiers
| code_info | Lot number: 2000930 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0783-2013%22
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