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

Lot, batch or date codesGTIN 00643169541856, Lot/Batch numbers: H5802984

Quantity recalled10 units

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-1410-2023
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 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.

Where it was distributed

Worldwide distribution - US Nationwide and the country of Canada.

Nationwide

Questions about this recall

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 00643169541856, Lot/Batch numbers: H5802984

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 91790

This product is part of a recall event; the main page for the event is Infinity Occipitocervical Upper Thoracic System recalled.

Reported	Class	Recall	Company	Reason	Where
26 Apr 2023	CLASS II	Infinity Occipitocervical Upper Thoracic System recalled	Medtronic Sofamor Danek USA	Other	Nationwide
26 Apr 2023	CLASS II	Infinity Occipitocervical Upper Thoracic System recalled	Medtronic Sofamor Danek USA	Other	Nationwide
26 Apr 2023	CLASS II	Infinity Occipitocervical Upper Thoracic System recalled	Medtronic Sofamor Danek USA	Other	Nationwide
26 Apr 2023	CLASS II	Infinity Occipitocervical Upper Thoracic System recalled	Medtronic Sofamor Danek USA	Other	Nationwide

More recalls from Medtronic Sofamor Danek USA

All 77

Reported	Class	Recall	Company	Reason	Where
3 Dec 2025Device	CLASS II	Catalyft PL & PL40 Expandable Interbody System labeled as recalled	Medtronic Sofamor Danek USA	Other	Nationwide
1 Nov 2023Device	CLASS II	Grafton DBM Crunch recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton DBM Matrix Strips recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton DBM Putty recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN
1 Nov 2023Device	CLASS II	Grafton Plus DBM Paste recalled by Medtronic Sofamor Danek USA	Medtronic Sofamor Danek USA	Processing Deviation	TN

Other Spinal Implants recalls

All 1,159

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Device	CLASS II	Extended Polyaxial Head, Attached Gimbal recalled	Seaspine Orthopedics	Other	Nationwide
30 Sep 2026Device	CLASS II	Medline Convenience Kits: Anterior Spine Pack recalled	Medline Industries	Other	Nationwide
9 Sep 2026Device	CLASS II	Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: ENT recalled	Avid Medical	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Halyard medical convenience kits labeled as: A-P PACK recalled	Avid Medical	Sterility	Nationwide