LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments. Labeled as the following sizes:
a. 5.5mm x 35mm;
b. 5.5mm x 40mm;
c. 5.5mm x 45mm;
d. 5.5mm x 50mm;
e. 5.5mm x 55mm;
f. 6.5mm x 35mm;
g. 6.5mm x 40mm;
h. 6.5mm x 45mm;
i. 6.5mm x 50mm;
j. 6.5mm x 55mm;
k. 6.5mm x 60mm;
l. 7.5mm x 35mm;
m. 7.5mm x 40mm;
n. 7.5mm x 50mm;
o. 7.5mm x 55mm;
p. 7.5mm x 60mm;
q. 8.5mm x 35mm;
r. 8.5mm x 40mm;
s. 8.5mm x 45mm;
t. 8.5mm x 50mm;
u.8.5mm x 55mm;
v. 8.5mm x 60mm;
Used in spinal fixation surgery.
Recall Date: Jan 27, 2022
Mfg:
Integrity Implants Inc.
Mfg Country:
United States
Recall ID: 91070
Product ID: 196647
Enforcement Date: Dec 14, 2022
Last Published: Dec 5, 2022
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Emert Number: Z-0418-2023
Emert Status: Notified