Recall Z-2363-2023— Medtronic Sofamor Danek USA, Inc

Name: FDA recall Z-2363-2023
Creator: U.S. Food and Drug Administration
Published: 2023-07-12

Class II · Ongoing

Class II FDA medical device recall by Medtronic Sofamor Danek USA, Inc, initiated 2023-07-12. It names one FDA 510(k) clearance: K140454. Product: CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K. Reason: Incorrect Laser Marking - Solera Awl Tip Tap.

Recalling firm: Medtronic Sofamor Danek USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-07-12
Firm location: Memphis, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K140454 — NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPSMedtronic Sofamor Danek USA, Inc.·cleared 2014-05-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

Reason for recall

Incorrect Laser Marking - Solera Awl Tip Tap

Data sourced from openFDA. This site is unofficial and independent of the FDA.