FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; 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.
- Recall number
- Z-1413-2023
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Product
- INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 34mm, REF 3604034; 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.
- Status
- Open, Classified
- Initiated
- 2023-02-16
- Posted
- 2023-04-19
- Terminated
- not on file
- Reason
- Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 13 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Lot, serial or model codes
- GTIN 00643169554696, Lot/Batch numbers: H5806345
- 510(k) numbers
- ["K163375"]
- PMA numbers
- not on file
- Product code
- KWP
- Firm FEI
- 1000477302
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28