Z-1337-2018 Class II Ongoing
FDA device recall Z-1337-2018 was initiated by Gyrus ACMI, Inc. on August 3, 2017 and is designated Class II. Reason for recall: "Chattering" when cutting burrs are used in bone. The recall status is ongoing. Affected quantity: 324.
Recall Details
- Product Type
- Devices
- Report Date
- April 18, 2018
- Initiation Date
- August 3, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 324
Product Description
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
Reason for Recall
"Chattering" when cutting burrs are used in bone.
Distribution Pattern
NM, MI, and TX EU, Australia, Japan, and Hong Kong
Code Information
Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), and MBUR7060FRCV (00821925036543) ALL LOTS MANUFACTURED BEFORE AUGUST 3, 2017