Reported Feb 3, 2021 · Terminated
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
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 Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
- Lot codes and dates
- Product Name / Catalog Number7601-04026
- Serial/Lot Number(s) AffectedLot
- KRBX Product Code (UDI)10888857349582
- Amount recalled
- 248 units/1 each
Where it was sold
- Nationwide
Why it was recalled
The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
This product could cause temporary or reversible health problems — stop using it.
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