Spinal Implant Screws Recalled for Defective Titanium Material
Medtronic is recalling INFINITY spinal implant screws manufactured with incorrect titanium material. The defect reduces the screw's gripping strength, risking implant performance in critical spinal fusion surgery.
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: This is a Class II medical device recall for defective spinal implant screws with reduced gripping strength due to incorrect titanium material. While no injuries have been reported, this is a risk-of-harm product used in critical spinal fusion applications where proper implant fixation is essential for patient safety.
Plain-English summary
Medtronic Sofamor Danek USA Inc is recalling INFINITY Occipitocervical Upper Thoracic System spinal implant screws (4.0mm x 22mm, REF 360PT4022) distributed worldwide, including the United States and Canada.
The affected screws were manufactured with an incorrect type of titanium material, which reduces the gripping strength of the screw head. These screws are intended for immobilization and stabilization of the spinal segment as an adjunct to fusion surgery in the craniocervical region, cervical spine, and upper thoracic spine.
The defect affects 5 batches with lot number H5806333 (GTIN 00643169552654). If you have had spinal surgery or believe you may have received one of these screws, contact your healthcare provider with the lot number to determine whether your implant was affected and what follow-up care may be appropriate.
The recalled product
- Product
- INFINITY Occipitocervical Upper Thoracic System, PARTIALLY THREADED MULTI AXIAL SCREW, Size: 4.0mm x 22mm, REF 360PT4022; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unctio
- Manufacturer
- Medtronic Sofamor Danek USA Inc
- Category
- Medical Device — Spinal Implant
- Affected units
- 2
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 00643169552654
- Lot/Batch numbers: H5806333
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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