Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric Recalled by OrthoPediatrics Corp Due to Complaint received from sales representative that the drill...

Date: October 18, 2012
Company: OrthoPediatrics Corp
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact OrthoPediatrics Corp directly.

Affected Products

4.5mm PLEO Osteotomy Guide. OrthoPediatrics Corp. markets a pediatric, extension osteotomy bone plate system. This system is marketed under the brand name OrthoPediatrics PediLock Extension Osteotomy Plate ( PLEO ). The product included in this recall is a Class I, 4.5mm PLEO Osteotomy Guide Instrument, common name: Guide, Surgical, Instrument. The PediLoc¿ Extension Osteotomy Plate is part of the OrthoPediatrics~PediLoc¿ system. The PediLoc¿ Extension Osteotomy Plate consists of 3.5mm and 4.5mm plates, left and right side specific. The PediLoc¿ Extension Osteotomy Plate is designed to fit the anatomy of the distal femur in children and adolescents, above the distal femoral physis. The distal section of the plate is designed so that three locking screws can be placed in the distal bone segment at an angle parallel to the distal femoral physis. The proximal portion of the plate is designed to accept locking or non-locking screws. The subject instrument of this recall is an adjunct instrument for the convenience of some surgeons who choose to use it. This instrument is not illustrated in the Surgical Technique, nor required to perform the procedure.

Quantity: 24

Why Was This Recalled?

Complaint received from sales representative that the drill guide tubes would not screw into replenishment instrument. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About OrthoPediatrics Corp

OrthoPediatrics Corp has 26 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report