Poly Component Trial, MPCS, packaged in the following sizes and configurations:
a) Poly Component Trial - MPCS 3x10L, REF 90-SRK-192310
b) Poly Component Trial - MPCS 3x10R, REF 90-SRK-191310
c) Poly Component Trial - MPCS 3x12L, REF 90-SRK-192312
d) Poly Component Trial - MPCS 3x12R, REF 90-SRK-191312
e) Poly Component Trial - MPCS 3x14L, REF 90-SRK-192314
f) Poly Component Trial - MPCS 3x14R, REF 90-SRK-191314
g) Poly Component Trial - MPCS 4x10L, REF 90-SRK-192410
h) Poly Component Trial - MPCS 4x10R, REF 90-SRK-191410
i) Poly Component Trial - MPCS 4x12L, REF 90-SRK-192412
j) Poly Component Trial - MPCS 4x12R, REF 90-SRK-191412
k) Poly Component Trial - MPCS 4x14L, REF 90-SRK-192414
l) Poly Component Trial - MPCS 4x14R, REF 90-SRK-191414
m) Poly Component Trial - MPCS 5x10L, REF 90-SRK-192510
n) Poly Component Trial - MPCS 5x10R, REF 90-SRK-191510
o) Poly Component Trial - MPCS 5x12L, REF 90-SRK-192512
p) Poly Component Trial - MPCS 5x12R, REF 90-SRK-191512
q) Poly Component Trial - MPCS 5x14L, REF 90-SRK-192514
r) Poly Component Trial - MPCS 5x14R, REF 90-SRK-191514
s) Poly Component Trial - MPCS 6x10L, REF 90-SRK-192610
t) Poly Component Trial - MPCS 6x10R, REF 90-SRK-191610
u) Poly Component Trial - MPCS 6x12L, REF 90-SRK-192612
v) Poly Component Trial - MPCS 6x12R, REF 90-SRK-191612
w) Poly Component Trial - MPCS 6x14L, REF 90-SRK-192614
x) Poly Component Trial - MPCS 6x14R, REF 90-SRK-191614
The Responsive Orthopedics (RO) Total Knee Arthroplasty (TKA) System is intended to restore alignment, stability, range of motion, and alleviate pain by replacing the articulating surfaces of the knee joint.
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code JWH·February 20, 2017