CD HORIZON Spinal System Solera Awl Tip Tap — Class II medical device recall Z-2363-2023
Ongoing recall by Medtronic Sofamor Danek USA, Inc, reported 2023-08-16, distributed nationwide. Incorrect Laser Marking - Solera Awl Tip Tap
| Recall number | Z-2363-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Sofamor Danek USA, Inc, Memphis, TN, United States |
| Recall initiated | 2023-07-12 |
| Classified | 2023-08-09 |
| Reported by FDA | 2023-08-16 |
| Distributed | Nationwide (US) |
| Quantity | 13 devices |
| UPC / GTIN / UDI-DI | 00643169540958, 00763000564087 |
| Lot numbers | 0011705200, 0011713764, 0011722871, 0011734643, 0011743681, CA21L046 |
| Model numbers | 9735465, NAV2006K |
Product
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Reason for recall
Incorrect Laser Marking - Solera Awl Tip Tap
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2363-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.