FDA-Device2013-12-04Class II
Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.
Synthes USA HQ, Inc.
Hazard
There is a possibility for the Guide Wires of the Slipped Capital Femoral Epiphysis System to stick in the cannulation of the drill bit and the drill bits to break during surgery.
Sold states
USA Nationwide Distribution
Affected count
166
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture fixation of large bones and large bone fragments and for slipped capital femoral epiphysis, pediatric femoral neck fractures, intercondylar femur fractures and sacroiliac joint disruptions.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0408-2014Don't want to check this manually?
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