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U.S. Department of Health and Human Services

Class 2 Device Recall Orthopediatrics PediLoc Tibial Plate System

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  Class 2 Device Recall Orthopediatrics PediLoc Tibial Plate System see related information
Date Initiated by Firm July 28, 2015
Date Posted September 18, 2015
Recall Status1 Terminated 3 on March 17, 2016
Recall Number Z-2796-2015
Recall Event ID 71933
510(K)Number K111086  
Product Classification Plate, fixation, bone - Product Code HRS
Product 3.5mm Non Locking Cortical Screw, in the PediLoc Tibial Plate System
Part number 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw. Used in pediatric orthopedics.
Code Information Part number 00-0903-2510, Lot number 150192-J
Recalling Firm/
Manufacturer		 OrthoPediatrics Corp
2850 Frontier Dr
Warsaw IN 46582-7001
For Additional Information Contact Mark Fox
574-268-6379
Manufacturer Reason
for Recall		 The 00-0903-2510, 3.5mm x 10mm Non Locking Cortical Screw, Lot # 150192-J package may contain a different screw. The screw in the package is a 00-0903-2526, 3.5mm x 26mm, and is etched correctly.
FDA Determined
Cause 2		 Packaging process control
Action OrthoPediatrics has initiated a Voluntary RECALL of Part # 00-0903-2510, 3.5mm Non Locking Cortical Screw, Lot # 150192-J, initially by contacting customers via telephone, and then by e-mailing notification letters on 7/28/2015. Customers returned the 5 mislabled screws, which were repacked with correct labeling. All recall activities were complete as of 8/14/2015.
Quantity in Commerce 5
Distribution Domestic: TN, IA Foreign: England VA/DOD: None
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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