Device product

Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system

Z-1337-2018

August 03, 2017

Class II

Product summary

Firm: Gyrus ACMI, Inc.
Event: Event 79548
Status: Ongoing
Classification: Class II
Quantity: 324
Official record key: device-enforcement:Z-1337-2018

Official wording

Reason: "Chattering" when cutting burrs are used in bone.

Code information: Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), and MBUR7060FRCV (00821925036543) ALL LOTS MANUFACTURED BEFORE AUGUST 3, 2017

Distribution pattern: NM, MI, and TX EU, Australia, Japan, and Hong Kong

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

"Chattering" when cutting burrs are used in bone.