Use caution Medical device recall · FDA · Published February 16, 2023

Medtronic Sofamor Danek Infinity Screw Recall: Weak Grip Risk

Medtronic Sofamor Danek recalls Infinity Multi-Axial Screws (4.0mm x 24mm) due to weak grip from incorrect titanium. Affected units have batch H5802983. Contact for remedy.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1409-2023Medical device Medtronic Sofamor Danek ›

Use caution until it’s fixed

Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws

Take action

Contact the company

Recalling firmMedtronic Sofamor Danek USA Inc1800 Pyramid Pl · Memphis, TN 38132-1703

✎ GovInfoNow plain-language explainer

Medtronic Sofamor Danek is recalling 5 batches of Infinity Multi-Axial Screws (4.0mm x 24mm) because they use incorrect titanium that reduces screw grip strength. This could lead to improper spinal stabilization during fusion surgery. Read more at govinfonow.com/recall/58875-medtronic-sofamor-danek-infinity-screw-recall-weak-grip-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/58875-medtronic-sofamor-danek-infinity-screw-recall-weak-grip-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1409-2023

Cite this page

“Medtronic Sofamor Danek Infinity Screw Recall: Weak Grip Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58875-medtronic-sofamor-danek-infinity-screw-recall-weak-grip-risk. Based on FDA recall #Z-1409-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1409-2023%22&limit=1).

The FDA announced on Feb. 16, 2023, that Medtronic Sofamor Danek USA Inc is recalling INFINITY Occipitocervical Upper Thoracic System MULTI AXIAL SCREWs due to the use of incorrect titanium that reduces gripping strength. The agency classified the Class II recall as voluntary and firm-initiated.

How to tell if you have it

Brand: Medtronic Sofamor Danek
Product: INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm
REF: 3604024
UPC: 00643169554689
Lot/Batch: H5802983

The hazard

The recall involves five batches of Infinity Multi-Axial Screws where the incorrect type of titanium was used, which reduces the gripping strength of the screw head. The FDA reported no specific incidents or injuries in this record.

Context

GovInfoNow's records show Medtronic Sofamor Danek USA Inc has 19 other recalls on record since Dec. 6, 2017. Other recent recalls of similar products include Medtronic 6069073 (Sept. 16, 2025), Medtronic Sofamor Danek Grafton DBM Putty Recall (Sept. 26, 2023), and Medtronic Sofamor Danek Magnifuse Bone Graft Recall (July 31, 2023). Other recent recalls of similar products include Synthes 2.4V TAP CORTEX SCREW Recall (Feb. 25, 2026), Tornier Perip Screw Recall (Dec. 19, 2025), and Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment Recall (Feb. 2, 2026).

How to tell if you have this one

Check for batch number H5802983 on the screw packaging. The product is part of the Infinity Occipitocervical Upper Thoracic System for spinal fusion.

Brand
Medtronic Sofamor Danek
Product
INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization
Category
Medical device

FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide distribution - US Nationwide and the country of Canada.

Recall number	Product, codes & lots	Quantity
Z-1409-2023	INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; 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.; GTIN 00643169554689, Lot/Batch numbers: H5802983	45 units
Z-1410-2023	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.; GTIN 00643169541856, Lot/Batch numbers: H5802984	10 units
Z-1411-2023	INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT4022; 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.; GTIN 00643169552654, Lot/Batch numbers: H5806333	2 units
Z-1412-2023	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.; GTIN 00643169554696, Lot/Batch numbers: H5806345	90 units
Z-1413-2023	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.; GTIN 00643169554696, Lot/Batch numbers: H5806345	13 units

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for batch number H5802983 on the screw packaging or surgical records.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution - US Nationwide and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 2 months after the firm started it.

Feb 16, 2023Firm started the recall
Apr 19, 2023FDA classified it Class II
Apr 26, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/58875-medtronic-sofamor-danek-infinity-screw-recall-weak-grip-risk">Medtronic Sofamor Danek Infinity Screw Recall: Weak Grip Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1409-2023 (February 16, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1409-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.