Z-2603-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 15, 2018
- Initiation Date
- July 9, 2018
- Termination Date
- May 7, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 47 units
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.
Distribution Pattern
US
Code Information
lot 0648247W