—#165709

Product

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

FDA product code: NKB — Thoracolumbosacral Pedicle Screw System
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K113174
Affected lot / code info: lot 0648247W

Why it was 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.

Root cause (FDA determination)

Employee error

Action the firm took

Medtronic distributed a voluntary removal notice via FedEx courier service to impacted U.S. consignees, delivered 09 July 2018. The notice stated provided a list of Loaner kits where the screws may also be found and provided the following instructions: " Instructions to Customers: 1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return via email to rs.sdmriskmgt@medtronic.com. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product. Transmission of this Field Safety Notice: 1.) This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. 2.) Please transfer this notice to other organizations on which this action has an impact. 3.) Please maintain a copy of this notice in your records."

Recalling firm

Firm: Medtronic Sofamor Danek USA Inc
Address: 1800 Pyramid Pl, Memphis, Tennessee 38132-1703

Distribution

Distribution pattern: US

Timeline

Recall initiated: 2018-07-09
Terminated: 2021-05-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #165709. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.