***REF S-3D*** 3mm Diamond Ball — Class II medical device recall Z-1377-2013
Terminated recall by The Anspach Effort, Inc., reported 2013-06-05, distributed nationwide. Due to three batches of product may have diamond grit size larger than intended applied to the head of the cut
| Recall number | Z-1377-2013 |
|---|---|
| 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 | 2011-03-04 |
| Classified | 2013-05-24 |
| Reported by FDA | 2013-06-05 |
| Terminated | 2013-12-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, FR, GB, MX, NL, SE |
| Quantity | 1,827 burrs |
| Lot numbers | D383039472, D403040236, D433040800 |
| Model numbers | 3MM |
Product
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
Reason for recall
Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.
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-1377-2013. 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.