Recall Z-1412-2023
Medtronic Sofamor Danek USA Inc · initiated February 16, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3.
Codes / lots: GTIN 00643169554696, Lot/Batch numbers: H5806345
Reason for recall
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
FDA-determined cause: Under Investigation by firm
Action taken
The firm issued an URGENT MEDICAL DEVICE RECALL NOTICE to its consignees on 02/16/2023 by UPS 2nd day mail. The letter explained the issue and the risk and requested the following actions be taken: Immediately identify, segregate, and quarantine affected products within your inventory. Pass this notice to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Contact Medtronic to return affected product: 1-800-933-2635 to receive an return authorization (RGA) and coordinate inventory replacement/credit. Reference FA1315. The letter also includes specific patient recommendations.
Details
- Recall number
- Z-1412-2023
- Initiated
- February 16, 2023
- Posted by FDA
- April 19, 2023
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Quantity
- 90 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recalling firm
- Medtronic Sofamor Danek USA Inc, Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1409-2023 Class II | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm…Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of… | 02/16/2023Open, Classified |
| Z-1410-2023 Class II | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm…Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of… | 02/16/2023Open, Classified |
| Z-1411-2023 Class II | INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW…Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of… | 02/16/2023Open, Classified |
| Z-1413-2023 Class II | INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm…Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of… | 02/16/2023Open, Classified |