OrthoPediatrics Corp: Medical Device Recall in 2012 - (Recall #: Z-2057-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.

Product Classification:

Class II

Date Initiated: June 14, 2012

Date Posted: August 1, 2012

Recall Number: Z-2057-2012

Event ID: 62351

Reason for Recall:

The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.

Status: Terminated

Product Quantity: 15 devices

Code Information:

Lot number: 7736703 and part number: 00-1050-4308

Distribution Pattern:

Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.

Voluntary or Mandated:

Voluntary: Firm initiated