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INFINITY Occipitocervical Upper Thoracic System recallZ-1413-2023 · Medtronic Sofamor Danek USA Inc · initiated Feb 16, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Sofamor Danek USA Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-1413-2023
Status
Open, Classified
Initiated by the company
Feb 16, 2023
Posted by the FDA
Apr 19, 2023
Recalling firm
Medtronic Sofamor Danek USA Inc
Quantity
13 units
Product code
KWP
FDA submissions
K163375
Distribution
Worldwide distribution - US Nationwide and the country of Canada.

Product description

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.

Code information (models, lots, serial numbers)

GTIN 00643169554696, Lot/Batch numbers: H5806345

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

34 devices cleared under K163375 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 91790).

Sources and updates

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