Spinal fixation screws recalled for reduced titanium gripping strength
Medtronic is recalling 90 INFINITY Multi-Axial Screws (Lot H5806345) due to incorrect titanium material that reduces screw head gripping strength. The defect affects 5 batches distributed in the US and Canada.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a medical device with a mechanical defect (reduced gripping strength) that poses a risk of harm. No injuries or illnesses have been reported, placing it in the 'risk-of-harm products where injury has not yet been reported' category per the severity rubric.
Plain-English summary
The INFINITY Occipitocervical Upper Thoracic System Multi-Axial Screws (4.0mm x 26mm, REF 3604026) are being recalled. These screws are used to immobilize and stabilize the spinal segment during fusion surgery for acute and chronic instabilities of the craniocervical junction, cervical spine (C1-C7), and upper thoracic spine (T1-T3).
The recall affects 90 units from 5 batches (Lot H5806345). Medtronic discovered that these screws were manufactured with an incorrect type of titanium, reducing the gripping strength of the screw head. No illnesses or injuries related to the defect have been reported.
The affected screws were distributed in the United States and Canada. Patients and healthcare providers who may have received or used these screws should contact Medtronic Sofamor Danek USA Inc. for further information.
The recalled product
- Product
- 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
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Category
- Medical Device — Spinal Implant
- Hazard
- material-defect
- mechanical-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN 00643169554696
- Lot/Batch numbers: H5806345
Distribution
Distributed nationwide across the United States.
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