FDA Device recall Z-1337-2018
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
- FDA Device
- Class II
- ongoing
- Published 2018-04-18
On 2018-04-18 the FDA classified a Class II recall of Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system by Gyrus Acmi, citing "Chattering" when cutting burrs are used in bone.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1337-2018 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2017-08-03 |
| Published | 2018-04-18 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Gyrus Acmi |
| Distribution | MI, NM, TX |
Product
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
Reason
"Chattering" when cutting burrs are used in bone.
Identifiers
| code_info | Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), and MBUR7060FRCV (00821925036543) A…Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), and MBUR7060FRCV (00821925036543) ALL LOTS MANUFACTURED BEFORE AUGUST 3, 2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1337-2018%22
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