Gyrus ACMI Round Cutting Burrs Recall: Chattering Risk During Bone Cutting
Gyrus ACMI recalls round cutting burrs for Diego Elite systems made before August 2017 due to chattering when cutting bone. Affected units have specific catalog numbers and lots.
Lower-risk recall
"Chattering" when cutting burrs are used in bone.
Contact the company
What happened, in plain English
Gyrus ACMI is recalling round cutting burrs used with the Diego Elite system that were made before August 3, 2017. The burrs can chatter when cutting bone, which may cause injury. This recall affects dental professionals using these specific burrs. Read more at govinfonow.com/recall/73260-gyrus-acmi-round-cutting-burrs-recall-chattering-risk-during-bone.
Source Summary by GovInfoNow · govinfonow.com/recall/73260-gyrus-acmi-round-cutting-burrs-recall-chattering-risk-during-bone · Updated September 19, 2026 · FDA enforcement record: FDA #Z-1337-2018
Cite this page
“Gyrus ACMI Round Cutting Burrs Recall: Chattering Risk During Bone Cutting.” GovInfoNow, updated September 19, 2026. https://govinfonow.com/recall/73260-gyrus-acmi-round-cutting-burrs-recall-chattering-risk-during-bone. Based on FDA recall #Z-1337-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1337-2018%22&limit=1).
Why it’s dangerous
The burrs can chatter when cutting bone, which may cause injury. This chattering is a mechanical issue that occurs during dental procedures involving bone tissue.
Who’s affected
Dental professionals who use the Diego Elite system with Gyrus ACMI round cutting burrs made before August 3, 2017 are most at risk. The recall applies to specific catalog numbers and lots.
How to tell if you have this one
Check for catalog numbers MBUR5060FRCV (00821925036529), MBUR6060FRCV (00821925036536), or MBUR7060FRCV (00821925036543) on the burrs. The burrs were manufactured before August 3, 2017.
- Brand
Gyrus ACMI- Category
Medical device
What to do — step by step
Check Product Details
Identify the catalog number and manufacturing date on the burrs to confirm if they are affected.
Where it went and when
Where it was distributed
Distributed in 3 states, and outside the U.S.
FDA distribution: “NM, MI, and TX EU, Australia, Japan, and Hong Kong” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Michigan, New Mexico, Texas.
Recall timeline
FDA published this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1337-2018 (August 3, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1337-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.