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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
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
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