Anspach Effort — Class II medical device recall Z-0783-2013
Terminated recall by The Anspach Effort, Inc., reported 2013-02-13, distributed in MA. Contact between the bur and bur guard could generate metal fragments that may or may not be visible to the sur
| Recall number | Z-0783-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Anspach Effort, Inc., Palm Beach Gardens, FL, United States |
| Recall initiated | 2012-09-05 |
| Classified | 2013-02-04 |
| Reported by FDA | 2013-02-13 |
| Terminated | 2014-08-13 |
| Distributed | MA |
| Quantity | 8 devices |
| Reason classes | foreign material |
| Lot numbers | 2000930 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0783-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.