Zimmer CAS

FDA Regulatory Profile

Zimmer CAS appears in FDA public data with 2 recalls, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1701-2015, Class II) was initiated on April 19, 2015. Its most recent 510(k) clearance was granted on September 11, 2014.

Summary

Total Recalls
2
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1701-2015Class IITibial Alignment Guide; Orthopedic Stereotaxic Instrument;April 19, 2015
Z-0495-2015Class IIPSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polyNovember 3, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K141601IASSIST KNEE SYSTEMSeptember 11, 2014
K131129CAS PSI SHOULDERAugust 20, 2013
K110054NAVITRACK SYSTEM - OS KNEE UNIVERSAL, CAS SAME INCISION TIBIA REFERENCEMarch 24, 2011