PlainRecalls
FDA Devices Moderate Class II Terminated

Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.MULTI-AXIAL SCREW FOR 5.5/6.0MM RODS, REF 55840005045

Reported: August 15, 2018 Initiated: July 9, 2018 #Z-2603-2018

Product Description

Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.MULTI-AXIAL SCREW FOR 5.5/6.0MM RODS, REF 55840005045

Reason for Recall

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.

Details

Units Affected
47 units
Distribution
US
Location
Memphis, TN

Frequently Asked Questions

What product was recalled? ▼
Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.MULTI-AXIAL SCREW FOR 5.5/6.0MM RODS, REF 55840005045. Recalled by Medtronic Sofamor Danek USA Inc. Units affected: 47 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 15, 2018. Severity: Moderate. Recall number: Z-2603-2018.

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