OrthoPediatrics Corp recalls 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking…

Recall date

July 28, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2796-2015

FDA classification

Class II

Brand / firm

OrthoPediatrics Corp

Sold / distributed

Domestic: TN, IA Foreign: England VA/DOD: None

Why it was recalled

The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.