Gyrus ACMI, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1337-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: August 3, 2017

Date Posted: April 18, 2018

Recall Number: Z-1337-2018

Event ID: 79548

Reason for Recall:

"Chattering" when cutting burrs are used in bone.

Status: Ongoing

Product Quantity: 324

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

Voluntary or Mandated:

Voluntary: Firm initiated