Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube — Class II medical device recall Z-0520-2021
Terminated recall by K2M, Inc, reported 2020-12-09, distributed nationwide. Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufact
| Recall number | Z-0520-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | K2M, Inc, Leesburg, VA, United States |
| Recall initiated | 2020-11-03 |
| Classified | 2020-12-02 |
| Reported by FDA | 2020-12-09 |
| Terminated | 2021-01-12 |
| Distributed | Nationwide (US) |
| Quantity | 4 devices |
| UPC / GTIN / UDI-DI | 10888857343948 |
| Model numbers | 7601-90001 |
Product
Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon Set Screw to the specified torque.
Reason for recall
Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on.
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-0520-2021. 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.