Recall Z-3130-2024
Medtronic Xomed, Inc. · initiated July 5, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
Codes / lots: UDI/DI 0076300004142, Lot Number 0219937928
Reason for recall
Product was distributed past expiration date.
FDA-determined cause: Under Investigation by firm
Action taken
Medtronic 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.
Details
- Recall number
- Z-3130-2024
- Initiated
- July 5, 2024
- Posted by FDA
- September 12, 2024
- Product code
- EQJ – Bur, Ear, Nose And Throat
- Quantity
- 1 unit
- Distribution
- International distribution to the country of Canada.
- Recalling firm
- Medtronic Xomed, Inc., Jacksonville, FL