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Terminated

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.

FDA Recall Z-0432-2013 · Posted 2012-11-22

Recalling FirmOrthoPediatrics Corp
Recall StatusTerminated
Product CodeHRS
Date Initiated2012-10-18
Date Terminated2013-09-18
Product Quantity24

Reason for Recall

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.

Firm Action

OrthoPediatrics sent an "URGENT RECALL" e-mail of the Trochar Scalpel Instrument to all affected customers. The e-mail identifies the product, problem, and actions to be taken by the customers. The e-mail states that the instrument has been manufactured incorrectly and will not work (function as intended). The threads in the instrument are faulty and the guide tubes will not thread in correctly. Customers will receive follow up information.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution-including the states of OH, NC, CO, FL, IN, MI, and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K083286ORTHOPEDIATRICS PEDILOC LOCKING PLATE SYSTEMOrthoPediatrics Corp. · 2009-01-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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