Recall Z-2796-2015— OrthoPediatrics Corp

Name: FDA recall Z-2796-2015
Creator: U.S. Food and Drug Administration
Published: 2015-07-28

Class II · Terminated

Class II FDA medical device recall by OrthoPediatrics Corp, initiated 2015-07-28, terminated 2016-03-17. It names one FDA 510(k) clearance: K111086. Product: 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.. Reason: 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..

Recalling firm: OrthoPediatrics Corp
Classification: Class II
Status: Terminated
Initiated: 2015-07-28
Terminated: 2016-03-17
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K111086 — ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEMOrthoPediatrics Corp.·cleared 2011-06-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.