Synthes USA

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
11
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0618-2018Class IINorian Drillable InjectAugust 10, 2017
Z-0617-2018Class IINorian Drillable InjectAugust 10, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemNovember 10, 2016
K141527DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEMMarch 30, 2015
K121601SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATEJuly 6, 2012
K112030SYNTHES RADIAL HEAD PROSTHESIS SYSTEMJune 19, 2012
K120854SYNTHES VA LCP ANKLE TRAUMA SYSTEMJune 18, 2012
K120717SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)May 8, 2012
K120070SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEMMarch 21, 2012
K120083SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)February 8, 2012
K1105923.7MM/5.0MM DYNAMIC LOCKING SCREWJuly 25, 2011
K1101252.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEMApril 21, 2011
K1103544.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEMMarch 4, 2011