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U.S. Department of Health and Human Services

Class 2 Device Recall OrthoPediatrics

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  Class 2 Device Recall OrthoPediatrics see related information
Date Initiated by Firm August 19, 2019
Create Date October 13, 2019
Recall Status1 Terminated 3 on October 26, 2020
Recall Number Z-0125-2020
Recall Event ID 83767
510(K)Number K172583  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product OrthoPediatrics Adolescent attachment bolt used with the Pediatric Nailing Platform (PNP) targeting arm- intended as an orthopedic implant system
(bolt is used to attach the targeting arm to the intramedullary fixation rod)
Part number: 01-1503-0032
Code Information Lot/serial number: 192432-B 192279-B 189808-A 187375-A 177577-A 183280-A 175221-A 174784-A UDI: 00841132149836
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		 Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
FDA Determined
Cause 2		 Device Design
Action OrthoPediatrics, Inc. notified Distributors by letter via email on 8/19/19 , stating reason for recall, health risk and action to take: Distributors have been instructed to review their inventory and the inventory at their clinical sites to recover the product. Questions contact: Kriss Anderson, VP of Quality Systems and Regulatory Affairs, at OrthoPediatrics at kanderson@orthopediatrics.com or 574-267-0897.
Quantity in Commerce 211 units
Distribution Nationwide Foreign: 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 = HSB and Original Applicant = OrthoPediatrics, Inc.
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