Genesys Orthopedics Systems, LLC

FDA Regulatory Profile

Genesys Orthopedics Systems, LLC appears in FDA public data with 2 recalls, 0 510(k) clearances, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0040-2018, Class II) was initiated on November 5, 2015.

Summary

Total Recalls
2
510(k) Clearances
0
Inspections
6
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0040-2018Class IIGenesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System November 5, 2015
Z-2677-2014Class IICircular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLocApril 2, 2014