Yukon Straight Rod spinal implants recalled for discoloration and contamination
K2M Inc. is recalling certain Yukon Straight Rod spinal implants due to discoloration from trace amounts of inorganic phosphorous compound. The contaminated devices may cause mild irritation or adverse tissue reactions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II FDA recall involving confirmed contamination of a medical device (spinal implant) that may cause adverse tissue reactions. No illnesses or injuries have been reported, making the maximum applicable score 3 per the rubric.
Plain-English summary
K2M Inc. is recalling certain Yukon Straight Rod spinal implants (catalog number 7601-540120, lot PCMW) due to discoloration caused by trace amounts of inorganic phosphorous compound. Laboratory analysis confirmed this contamination in some units.
The inorganic phosphorous contamination may produce a mild irritating or inflammatory response. Adverse local tissue reactions may occur related to the chemical properties of the nonconforming rod when in contact with surrounding tissue.
A total of 53 affected devices were distributed: 19 to the United States (Florida, Georgia, Nebraska, Nevada, New York, Ohio, Oklahoma, and South Carolina) and 34 internationally (Canada, European Union, and Hong Kong).
The recalled product
- Product
- Yukon Straight Rod 4.0 x120mm; Cat# 7601-540120. Used to provide immobilization and stabilization of spinal segments.
- Manufacturer
- K2M, Inc.
- Category
- Medical Device — Spinal Implant
- Hazard
- contamination
- tissue-irritation
- cytotoxicity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 10888857326804 Lot PCMW
Distribution
Distributed in 8 states:
- FL
- GA
- NE
- NV
- NY
- OH
- OK
- SC
Related recalls
Same category
- SevereMedline angiography and radiology convenience kits recalled for unapproved design changes
FDA (Devices) · 2026-07-01
- SevereDa Vinci surgical system operative components with E-brake retainer pin defect
FDA (Devices) · 2026-07-01
- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- SevereMedical Device Surgical Kits with Syringes Recalled for Unapproved Design Changes
FDA (Devices) · 2026-07-01