Spinal implant screws recalled due to defective titanium material
Medtronic is recalling 45 units of INFINITY Multi-Axial Screws (lot H5802983) worldwide because incorrect titanium was used, reducing the screw head's gripping strength. No illnesses or injuries have been reported.
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: This is an FDA Class II medical device recall involving a structural defect (incorrect titanium material) in a spinal implant. Although the defect could potentially affect device performance and patient safety, no illnesses or injuries have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported warrant a High severity score.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling 45 units of INFINITY Occipitocervical Upper Thoracic System Multi-Axial Screws (Size 4.0mm x 24mm, REF 3604024, Lot H5802983) because the screws were manufactured using an incorrect type of titanium. This material defect reduces the gripping strength of the screw head, which could affect the device's ability to provide proper immobilization and stabilization during spinal fusion surgery.
These screws are intended for immobilization and stabilization of the spinal segment as an adjunct to fusion for acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7), and the upper thoracic spine (T1-T3). The affected devices have been distributed worldwide, including throughout the United States and Canada.
No illnesses or injuries related to this defect have been reported to date. Healthcare facilities that have received these products should stop using them and contact Medtronic for instructions on replacement or return. Patients who have already received these implants should consult with their healthcare provider about their spinal fusion device.
The recalled product
- Product
- INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; 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
- Category
- Medical Device — Spinal Implant
- Affected units
- 45
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 00643169554689
- Lot/Batch numbers: H5802983
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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