Yukon Polyaxial Screw Size 4 — Class II medical device recall Z-0931-2021
Terminated recall by K2M, Inc, reported 2021-02-03, distributed nationwide. The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diame
| Recall number | Z-0931-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | K2M, Inc, Leesburg, VA, United States |
| Recall initiated | 2020-12-14 |
| Classified | 2021-01-27 |
| Reported by FDA | 2021-02-03 |
| Terminated | 2023-07-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, NL, SG |
| UPC / GTIN / UDI-DI | 10888857349582 |
| Model numbers | 7601-04026 |
Product
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
Reason for recall
The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
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-0931-2021. 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.