—#198854

Product

INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 32mm, REF 3604532; 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.

FDA product code: KWP — Appliance, Fixation, Spinal Interlaminal
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K163375
Affected lot / code info: GTIN 00643169541856, Lot/Batch numbers: H5802984

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Medtronic Sofamor Danek USA Inc
Address: 1800 Pyramid Pl, Memphis, Tennessee 38132-1703

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.

Timeline

Recall initiated: 2023-02-16
Posted by FDA: 2023-04-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #198854. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.