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U.S. Department of Health and Human Services

Class 2 Device Recall OrthoPediatrics Pediloc Locking Plate System

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 Class 2 Recall
OrthoPediatrics Pediloc Locking Plate System
see related information
Date Posted July 20, 2012
Recall Status1 Terminated on April 30, 2013
Recall Number Z-2057-2012
Recall Event ID 62351
Premarket Notification
510(K) Number
K083286 
Product Classification Plate, Fixation, Bone - Product Code HRS
Product OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compression Femur 8 Hole Plate Right. Used for pediatric patients as indicated for pelvic, small and long bone fractures.
Code Information Lot number: 7736703 and part number: 00-1050-4308
Recalling Firm/
Manufacturer
OrthoPediatrics Corp
2850 Frontier Dr
Warsaw, Indiana 46582-7001
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Greg Teghtmeyer
574-268-6379
Manufacturer Reason
for Recall
The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action On 15-June-2012, a follow-up, URGENT Recall of MIS-BRANDED PediLoc Locking Plate e-mail was sent to all Distributors and direct representatives to provide them with a written notification of the voluntary recall. The e-mail identified the affected product and the reason for the recall. It also instructed them to quarantine all identified devices from the affected lot number immediately. A certified Voluntary Recall notice was also sent as a follow up along with a return prepaid pouch for the return of the recalled device(s) and Mandatory Reply Form.
Quantity in Commerce 15 devices
Distribution Worldwide Distribution -- USA, including states of IN, GA, MI, FL, MO, OH, and SC and country of Australia.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = ORTHOPEDIATRICS, CORP.
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