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U.S. Department of Health and Human Services

Class 2 Device Recall OrthoPediatrics PediLoc Locking Cannulated Blade Plate System

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  Class 2 Device Recall OrthoPediatrics PediLoc Locking Cannulated Blade Plate System see related information
Date Initiated by Firm April 19, 2013
Date Posted June 12, 2013
Recall Status1 Terminated 3 on September 19, 2013
Recall Number Z-1534-2013
Recall Event ID 65091
510(K)Number K110959  
Product Classification Screw, fixation, bone - Product Code HWC
Product 90 Degree Cannulated Infant Blade Plate 25mm 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.
Code Information All lot numbers are affected. Catalog No. 00-1200-1000
Recalling Firm/
Manufacturer		 OrthoPediatrics Corp
2850 Frontier Dr
Warsaw IN 46582-7001
For Additional Information Contact Greg Teghtmeyer
574-268-6379
Manufacturer 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.
FDA Determined
Cause 2		 Device Design
Action OrthoPediatrics sent an Urgent Voluntary Recall notifiation via telephone and email to all affected consignees. The letter instructed consignees to take possession of any affected devices and quarantine immediately. A Mandatory Reply Form is included with the notification letter to be completed and returned. Please contact Greg Teghtmeyer if you have any questions (574-268-6379).
Quantity in Commerce 130 devices were shipped
Distribution USA Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = ORTHOPEDIATRICS, CORP
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