FDA Device recall Z-1307-2022
Yukon Straight Rod 4.0 x120mm
- FDA Device
- Class II
- ongoing
- Published 2022-07-06
On 2022-07-06 the FDA classified a Class II recall of Yukon Straight Rod 4.0 x120mm by K2m, citing 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 irri….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1307-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-13 |
| Published | 2022-07-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | K2m |
| Distribution | FL, GA, NE, NV, NY, OH, OK, SC |
Product
Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
Reason
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.
Identifiers
| code_info | UDI-DI: 10888857326804 Lot PCMW |
|---|
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-1307-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.