Yukon Straight Rod 4 — Class II medical device recall Z-1307-2022
Ongoing recall by K2M, Inc., reported 2022-07-06, distributed in FL, GA, NE, NV, NY, OH, OK, SC. Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace am
| Recall number | Z-1307-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | K2M, Inc., Leesburg, VA, United States |
| Recall initiated | 2022-06-13 |
| Classified | 2022-06-30 |
| Reported by FDA | 2022-07-06 |
| Distributed | FL, GA, NE, NV, NY, OH, OK, SC |
| Countries outside the US | CA, HK |
| UPC / GTIN / UDI-DI | 10888857326804 |
| Model numbers | 7601-540120 |
Product
Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Reason for recall
Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or inflammatory response; adverse local tissue reactions may occur related to cytotoxicity with the nonconforming rod and surrounding tissue.
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-1307-2022. 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.