K2M recalls Yukon Straight Rod 4.0x120mm (Cat# 7601-540120) due to trace inorganic phosphorous causing mild irritation. Affected spinal stabilization rods may cause tissue inflammation.
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.
K2M is recalling Yukon Straight Rods 4.0 x120mm (Cat# 7601-540120) because some units contain trace inorganic phosphorous that can cause mild irritation or tissue inflammation. This is a safety issue for people using spinal stabilization devices.
The rods contain trace amounts of inorganic phosphorous that can cause mild irritation or inflammation when in contact with tissue. This may lead to local tissue reactions due to cytotoxicity, but does not cause serious injury in normal use.
People who own or use K2M Yukon Straight Rods 4.0 x120mm for spinal stabilization are affected. Those with sensitive skin or existing tissue conditions may be at slightly higher risk.
Check for the product name 'Yukon Straight Rod 4.0 x120mm' with Cat# 7601-540120. The lot number is PCMW (UDI-DI: 10888857326804).
Verify the product name and lot number (PCMW) to confirm if your rod is affected.
The recall indicates a mild irritation risk from trace phosphorous, but does not cause serious injury in normal use.
Check for the product name 'Yukon Straight Rod 4.0 x120mm' with Cat# 7601-540120 and lot number PCMW (UDI-DI: 10888857326804).
The recall does not specify a remedy, so check with K2M directly for guidance.
We’ve drafted a message you can send K2M to request your refund or repair — edit it as you like.
Subject: Recall Z-1307-2022 — K2M K2M Hello, I own a K2M that is covered by recall Z-1307-2022 from K2M. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.