Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
Reported: February 3, 2021 Initiated: December 14, 2020 #Z-0931-2021
Product Description
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
Reason for Recall
The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
Details
- Recalling Firm
- K2M, Inc
- Units Affected
- 248 units/1 each
- Distribution
- Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore
- Location
- Leesburg, VA
Frequently Asked Questions
What product was recalled? ▼
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System. Recalled by K2M, Inc. Units affected: 248 units/1 each.
Why was this product recalled? ▼
The Yukon polyaxial screw used in the Yukon Spinal System was incorrectly laser marked with size 5.0 mm (diameter) & 24 mm (length).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 3, 2021. Severity: Moderate. Recall number: Z-0931-2021.
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