FDAFDA · Food and drugs·Recall number Z-0520-2021
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.
Published December 9, 2020 · Recall initiated: November 3, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- K2M, Inc
- Distributor
- US Nationwide distribution.
- Lot
- Catalog Number/REF 7601-90001 LOT KTGG GTIN 10888857343948
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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