OrthoPediatrics Corp: Medical Device Recall in 2015 - (Recall #: Z-2796-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 28, 2015

Date Posted: September 30, 2015

Recall Number: Z-2796-2015

Event ID: 71933

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.

Status: Terminated

Product Quantity: 5

Code Information:

Part number 00-0903-2510, Lot number 150192-J

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated