Gyrus ACMI Round Cutting Burrs - to be used with the recall
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
Why was Gyrus ACMI Round Cutting Burrs - to be used with the recalled?
"Chattering" when cutting burrs are used in bone.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), and MBUR7060FRCV (00821925036543) ALL LOTS MANUFACTURED BEFORE AUGUST 3, 2017
- Product
- Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
- Recalling firm
- Gyrus ACMI, Inc.
- Quantity
- 324
- Distribution
- NM, MI, and TX EU, Australia, Japan, and Hong Kong
- Recall date
- April 18, 2018
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)