Medtronic ENT Ultra Round Steel Cutting Bur, Model Number REF 31313069
FDA device recall Z-3130-2024 · posted 2024-09-12 · Open, Classified
Recall details
- Recalling firm
- Medtronic Xomed, Inc.
- Reason for recall
- Product was distributed past expiration date.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- EQJ
- Quantity affected
- 1 unit
- Distribution
- International distribution to the country of Canada.
- Date initiated
- 2024-07-05
- Date posted
- 2024-09-12
- Location
- Jacksonville, FL
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