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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 Device Recall OrthoPediatrics Pediloc Locking Plate System see related information
Date Initiated by Firm June 14, 2012
Date Posted July 20, 2012
Recall Status1 Terminated 3 on April 30, 2013
Recall Number Z-2057-2012
Recall Event ID 62351
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 IN 46582-7001
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		 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 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 = HRS and Original Applicant = ORTHOPEDIATRICS, CORP.
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