Device product
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
Z-0931-2021
Product summary
- Firm
- K2M, Inc
- Event
- Event 87075
- Status
- Terminated
- Classification
- Class II
- Quantity
- 248 units/1 each
- Official record key
device-enforcement:Z-0931-2021
Official wording
Reason: The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
Code information: Product Name / Catalog Number: 7601-04026 Serial/Lot Number(s) Affected: Lot KRBX Product Code (UDI): 10888857349582
Distribution pattern: Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore
Derived failure modes
-
Unknown
The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).