Device product
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Z-2363-2023
Product summary
- Event
- Event 92749
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13 devices
- Official record key
device-enforcement:Z-2363-2023
Official wording
Reason: Incorrect Laser Marking - Solera Awl Tip Tap
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.
Derived failure modes
-
Unknown
Incorrect Laser Marking - Solera Awl Tip Tap