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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Event Detail

Event ID 63554
Product Type Devices
Status Ongoing
Recalling Firm OrthoPediatrics Corp
City Warsaw
State IN
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-18
Initial Firm Notification of
Consignee or Public
Distribution Pattern Nationwide Distribution-including the states of OH, NC, CO, FL, IN, MI, and TX.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Part number: 01-1050-0066 and 01-1050-0067 Lot numbers: 7861001 and 7861101 only Class II 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. 26 Z-0432-2013