Z-1412-2023Class II

INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; for...

Name: Z-1412-2023 INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; for...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2023-02-16
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2023-02-16 / Open, Classified

FDA source

Medtronic Sofamor Danek USA Inc began a recall of INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 26mm, REF 3604026; for immobilization and stabilization of spinal segment as... on 2023-02-16. FDA classified it as Class II and gives the reason as "Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1412-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-16
Posted: 2023-04-19
Recalling firm: Medtronic Sofamor Danek USA Inc
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.
Product code: KWP Appliance, Fixation, Spinal Interlaminal
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 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 in commerce: 90 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: GTIN 00643169554696, Lot/Batch numbers: H5806345

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1412-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1409-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-19
Z-1410-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-19
Z-1411-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-19
Z-1412-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-19
Z-1413-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-19

Product code KWP

K163375Class IIINFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc. / cleared 2017-08-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)