Gyrus ACMI Round Cutting Burrs Recalled for Chattering During Bone Cutting
Gyrus ACMI is recalling 324 Round Cutting Burrs used with the Diego Elite system because they chatter when cutting bone.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect in a surgical instrument that could impact procedure safety, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Gyrus ACMI, Inc. is recalling 324 units of Gyrus ACMI Round Cutting Burrs intended for use with the Diego Elite system. The recall affects catalog numbers MBUR5060FRCV, MBUR6060FRCV, and MBUR7060FRCV, specifically all lots manufactured before August 3, 2017.
The reason for the recall is that the cutting burrs exhibit "chattering" when used in bone. This performance issue may affect the precision of the surgical procedure.
The affected products were distributed in New Mexico, Michigan, and Texas, as well as in the European Union, Australia, Japan, and Hong Kong. Users should stop using the affected burrs and contact Gyrus ACMI, Inc. for further instructions.
The recalled product
- Product
- Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
- Manufacturer
- Gyrus ACMI, Inc.
- Affected units
- 324
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Catalog No. (UDI-DI): MBUR5060FRCV (00821925036529)
- MBUR6060FRCV (00821925036536)
- and MBUR7060FRCV (00821925036543) ALL LOTS MANUFACTURED BEFORE AUGUST 3
- 2017
Distribution
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