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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 10
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.
Part of a larger recall action
This product is one of 5 recalled by Medtronic Sofamor Danek USA Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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