FDA Device recall Z-2363-2023
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
- FDA Device
- Class II
- ongoing
- Published 2023-08-16
On 2023-08-16 the FDA classified a Class II recall of CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K by Medtronic Sofamor Danek Usa, citing incorrect Laser Marking - Solera Awl Tip Tap.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2363-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-12 |
| Published | 2023-08-16 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Sofamor Danek Usa |
| Distribution | US |
Product
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Reason
Incorrect Laser Marking - Solera Awl Tip Tap
Identifiers
| code_info | SOLERA AWLTIPTAP (REF NAV2006K GTIN 00643169540958, Batch CA21L046). The Component (CFN NAV2006K) is packaged inside th…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 history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2363-2023%22
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