Medtronic Sofamor Danek USA, Inc: Medical Device Recall in 2023 - (Recall #: Z-2363-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

Product Classification:

Class II

Date Initiated: July 12, 2023

Date Posted: August 16, 2023

Recall Number: Z-2363-2023

Event ID: 92749

Reason for Recall:

Incorrect Laser Marking - Solera Awl Tip Tap

Status: Ongoing

Product Quantity: 13 devices

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

Distribution Pattern:

US Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.

Voluntary or Mandated:

Voluntary: Firm initiated