Gyrus ACMI Round Cutting Burrs — Class II medical device recall Z-1337-2018
Ongoing recall by Gyrus ACMI, Inc., reported 2018-04-18, distributed in MI, NM, TX. "Chattering" when cutting burrs are used in bone.
| Recall number | Z-1337-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Gyrus ACMI, Inc., Bartlett, TN, United States |
| Recall initiated | 2017-08-03 |
| Classified | 2018-04-10 |
| Reported by FDA | 2018-04-18 |
| Distributed | MI, NM, TX |
| Countries outside the US | AU, HK, JP |
| Quantity | 324 |
| UPC / GTIN / UDI-DI | 00821925036529, 00821925036536, 00821925036543 |
| Model numbers | MBUR5060FRCV, MBUR6060FRCV, MBUR7060FRCV |
Product
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
Reason for recall
"Chattering" when cutting burrs are used in bone.
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-1337-2018. 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.