ClearanceBrief
Recall Z-3130-2024 ยท EQJ Bur, Ear, Nose And Throat

Medtronic Xomed, Inc.

Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069

DateSep 12, 2024 (initiated Jul 5, 2024)
StatusOpen, Classified
ReasonProduct was distributed past expiration date.
Root causeUnder Investigation by firm
ActionMedtronic issued an URGENT: MEDICAL DEVICE RECALL notice to its sole consignee on 07/05/2024 via in person visit. The notice explained the problem, potential risk if used, and requested the product be quarantined.
Quantity1 unit
DistributionInternational distribution to the country of Canada.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.