Medtronic INFINITY Spinal Fusion Screws Recalled for Material Defect
Medtronic is recalling 10 units of INFINITY Multi-Axial Screws distributed in the US and Canada because incorrect titanium material reduces gripping strength in affected lots.
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: FDA Class II medical device with material defect affecting spinal fusion screws. The hazard (reduced gripping strength and risk of inadequate spinal stabilization) places this in the risk-of-harm category without confirmed injuries to date.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 10 units of INFINITY Occipitocervical Upper Thoracic System Multi-Axial Screws (4.0mm x 32mm, REF 3604532) used for immobilization and stabilization of the spine during fusion procedures.
The recalled screws were manufactured using an incorrect type of titanium, which reduces the gripping strength of the screw head. Lot H5802984 is affected. This defect creates a risk of inadequate spinal stabilization.
The affected product was distributed worldwide, including the United States and Canada.
The recalled product
- Product
- 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
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Hazard
- material-defect
- structural-failure-risk
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 00643169541856
- Lot/Batch numbers: H5802984
Distribution
Distributed nationwide across the United States.
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