INFINITY Multi-Axial Spinal Screws Recalled for Titanium Material Defect
Medtronic is recalling INFINITY Multi-Axial Spinal Screws due to incorrect titanium material used in manufacturing, which reduces the gripping strength of the screw head. The affected screws are used for spinal fusion and stabilization.
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 a material defect affecting spinal fusion hardware. No injuries or illnesses have been reported to date, but reduced gripping strength poses a potential risk of spinal instability. Classified as High per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling INFINITY Occipitocervical Upper Thoracic System Multi-Axial Screws (4.0mm x 34mm, REF 3604034). 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 was initiated because incorrect titanium material was used in the manufacturing of affected batches of these screws. This material defect reduces the gripping strength of the screw head, which could compromise the stability and integrity of the spinal fusion. The recalled lot is H5806345, with a total of 13 units affected.
The affected screws have been distributed worldwide, including throughout the United States and Canada.
Patients and healthcare providers should contact Medtronic immediately for instructions regarding product return and replacement. Healthcare facilities should cease using the affected screws.
The recalled product
- Product
- 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…
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Affected units
- 13
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.
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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