CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
FDA Recall #Z-2363-2023 — Class II — July 12, 2023
Product Description
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Reason for Recall
Incorrect Laser Marking - Solera Awl Tip Tap
Recalling Firm
Medtronic Sofamor Danek USA, Inc — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
13 devices
Distribution
US Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.
Code Information
SOLERA AWLTIPTAP (REF NAV2006K GTIN 00643169540958, Batch CA21L046). The Component (CFN NAV2006K) is packaged inside the SOLERA TAPS Kit (REF 9735465, GTIN 00763000564087), Lot Numbers: 0011743681, 0011734643, 0011713764, 0011722871, 0011705200
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated