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.
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 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…
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Category
- Medical Device — Spinal Implant
- Affected units
- 90
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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