Medtronic CD HORIZON Spinal System is intended to help recall
Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the…
Why was Medtronic CD HORIZON Spinal System is intended to help recalled?
This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm diameter screw when the actual screw diameter aligns with 5.0 diameter screw size requirements.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
lot 0648247W
- Product
- Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the…
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 47 units
- Distribution
- US
- Recall date
- August 15, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)