OrthoPediatrics Corp: Medical Device Recall in 2014 - (Recall #: Z-0934-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

3.5mm Locking Cortical Bone Screw, T15 Hexalobe, Self Tapping, 20mm Part No. 00-0903-2620 OrthoPediatrics Pediloc" Tibia Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia. The subject recalled device is a Bone Screw designed for use with this system.

Product Classification:

Class II

Date Initiated: January 8, 2014

Date Posted: February 12, 2014

Recall Number: Z-0934-2014

Event ID: 67302

Reason for Recall:

OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2620, 3.5MM Locking Cortical Screw, Lot # 009SV because the device within the package may be incorrect. These packages incorrectly contain a 3.5mm Non Locking Cortical Screw # 00-1050-3524.

Status: Terminated

Product Quantity: 12 units

Code Information:

Lot 009SV

Distribution Pattern:

Worldwide Distribution - USA including OK, KY, FL, LA, OH, CO, MO, MN and Internationally to Ireland, Saudi Arabia, Italy, Turkey, South Africa, and Germany.

Voluntary or Mandated:

Voluntary: Firm initiated