medical Class II Updated 2020-12-09

K2M, Inc recalls Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - P

Recalled 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 Set Screw to the specified torque.


Hazard / Issue

Shafts do not pass through the inner cannula of the Anti-Torque Alignment Tube from Lot KTGG due to a manufacturing nonconformance. This could result in a delay of surgery or result in surgical intervention later on.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog Number/REF 7601-90001 LOT KTGG GTIN 10888857343948
View official government recall

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