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
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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
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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.
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510(K) Database | 510(K)s with Product Code = HRS
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