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
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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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