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U.S. Department of Health and Human Services

Enforcement Report - Week of June 19, 2013

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Product Detail

Product Description 90 Degree Cannulated Infant Blade Plate 30mm x 5mm x 3 Hole Product Usage: The OrthoPediatrics Locking Cannulated Blade Plate System is intended for fixation of long bone fractures and osteotomies in all pediatric subgroups (except neonates) and in small stature adults. Specific indications include: intertrochanteric derotation and varus osteotomies, femoral neck and pertrochanteric fractures, intertrochanteric valgus osteotomies, proximal and distal tibial osteotomies and humeral fractures and osteotomies.
Recall Number Z-1535-2013
Classification Class II
Code Info All lot numbers are affected. Catalog No. 00-1200-1001
Product Distributed Qty 130 devices were shipped
Reason For Recall Post Market Surveillance of the 90 degree Cannulated Infant Blade Plate indicated that there have been five reports concerning bending of the plate intra-operatively.

Event Detail

Event Id 65091
Product Type Devices
Status Ongoing
Recalling Firm OrthoPediatrics Corp
City Warsaw
State IN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-19
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern USA Nationwide Distribution