CLASS II ONGOING Device recall · Reported 26 Apr 2023 · FDA Enforcement Report
Infinity Occipitocervical Upper Thoracic System recalled
Medtronic Sofamor Danek USA is recalling Infinity Occipitocervical Upper Thoracic System, Multi Axial Screw, Size, distributed nationwide in the US. The recall was initiated on 16 Feb 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1412-2023
- FDA event ID
- 91790
- Recalling firm
- Medtronic Sofamor Danek USA, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Feb 2023
- FDA classified
- 19 Apr 2023
- Reported
- 26 Apr 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 16 Feb 2023 | Recall initiated by company | |
| 19 Apr 2023 | Classified by FDA | +62 days |
| 26 Apr 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - US Nationwide and the country of Canada.
Questions about this recall
Is Infinity Occipitocervical Upper Thoracic System, Multi Axial Screw, Size recalled?
Yes. Medtronic Sofamor Danek USA recalled Infinity Occipitocervical Upper Thoracic System, Multi Axial Screw, Size on 16 Feb 2023. The recall is Class II and its status is Ongoing. Recall number Z-1412-2023.
Why was it recalled?
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Which lots are affected?
GTIN 00643169554696, Lot/Batch numbers: H5806345
Where was it sold?
Worldwide distribution - US Nationwide and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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