Reported Dec 9, 2020 · Terminated
Yukon OCT Spinal System Yukon Anti-Torque Alignment Tube - Product Usage: The Anti-Torque Alignment Tube (the Alignment…
K2M, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: K2M, Inc · 600 Hope Pkwy SE · Leesburg, VA · 20175-4428
Is this the product you have?
- Yukon OCT Spinal System Yukon Anti-Torque
- Alignment Tube - Product UsageThe 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
- Lot codes and dates
- Catalog Number/REF 7601-90001 LOT KTGG GTIN 10888857343948
- Amount recalled
- 4 devices
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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