Z-2363-2023 Class II Ongoing
FDA device recall Z-2363-2023 was initiated by Medtronic Sofamor Danek USA, Inc on July 12, 2023 and is designated Class II. Reason for recall: Incorrect Laser Marking - Solera Awl Tip Tap The recall status is ongoing. Affected quantity: 13 devices.
Recall Details
- Product Type
- Devices
- Report Date
- August 16, 2023
- Initiation Date
- July 12, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13 devices
Product Description
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Reason for Recall
Incorrect Laser Marking - Solera Awl Tip Tap
Distribution Pattern
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