K2M Recalls Yukon Anti-Torque Alignment Tubes Due to Manufacturing Defect
K2M, Inc. is recalling four Yukon Anti-Torque Alignment Tubes from Lot KTGG because shafts do not pass through the inner cannula, potentially delaying surgery.
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: The recall involves a medical device defect that could result in surgical delays or later intervention, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
K2M, Inc. is recalling four units of the Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube. The affected devices are identified by Catalog Number/REF 7601-90001, LOT KTGG, and GTIN 10888857343948. These devices were distributed nationwide in the United States.
The recall is due to a manufacturing nonconformance where shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube. This defect could result in a delay of surgery or require surgical intervention later on.
Healthcare providers and facilities that have received these specific devices should stop using them and contact K2M, Inc. for further instructions on the recall process.
The recalled product
- Product
- Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment Tube ) provides counter rotation to reduce the torque applied to the anatomy when the size 15 Torque limiting shaft (the shaft is used to tighten the Yukon S
- Manufacturer
- K2M, Inc
- Category
- Medical Device — Spinal System
- Affected units
- 4
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)
- Catalog Number/REF 7601-90001 LOT KTGG GTIN 10888857343948
Distribution
Distributed nationwide across the United States.
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