Recall Z-1337-2018 ยท EQJ Bur, Ear, Nose And Throat
Gyrus ACMI, Inc.
Gyrus ACMI Round Cutting Burrs - to be used with the Diego Elite system
| Date | Mar 20, 2018 (initiated Aug 3, 2017) |
| Status | Open, Classified |
| Reason | "Chattering" when cutting burrs are used in bone. |
| Action | As a result, OSTA will issue a Field Safety Notice (FSN) to all customers that received variable exposure burrs of 5mm or greater diameter. The FSN will inform them of the concern and will advise to exercise due caution if using the affected device in proximity to sensitive or vital anatomical structures. On September 6, 2017 the firm sent a URGENT: MEDICAL DEVICE FIELD SAFETY NOTICE to the attention of the Surgical Risk Management Department for the following products: MBUR5060FRCV - Burr, 5mm Round Cutting, Variable Exposure, Standard Length, MBUR6060FRCV - Burr, 6mm Round Cutting, Variabl |
| Quantity | 324 |
| Distribution | NM, MI, and TX EU, Australia, Japan, and Hong Kong |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.