K2M, Inc recalls Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
- Recall date
- December 14, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0931-2021
- FDA classification
- Class II
- Brand / firm
- K2M, Inc
- Sold / distributed
- Domestic: Nationwide Foreign: Australia, Canada, Netherlands, Singapore
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).
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026), component of YUKON Spinal System
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