FDA Enforcement
Class II
Ongoing
Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
Recall: Z-3130-2024
·
Reported September 18, 2024
Enforcement
- Recall Number
- Z-3130-2024
- Event ID
- 95162
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medtronic Xomed, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Visit
- Report Date
- September 18, 2024
- Initiation Date
- July 5, 2024
- Classification Date
- September 12, 2024
- Address
- 6743 Southpoint Dr N, Jacksonville, FL, 32216-6218, United States
Description
Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
Reason
Product was distributed past expiration date.
Code Info
UDI/DI 0076300004142, Lot Number 0219937928
Distribution
International distribution to the country of Canada.
Quantity
1 unit