Medtronic Sofamor Danek USA Inc: Medical Device Recall in 2018 - (Recall #: Z-2603-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: July 9, 2018

Date Posted: August 15, 2018

Recall Number: Z-2603-2018

Event ID: 80541

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.

Status: Terminated

Product Quantity: 47 units

Code Information:

lot 0648247W

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated