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U.S. Department of Health and Human Services

Class 2 Device Recall thoracolumbosacral pedicle screw system

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  Class 2 Device Recall thoracolumbosacral pedicle screw system see related information
Date Initiated by Firm August 03, 2017
Create Date February 14, 2018
Recall Status1 Terminated 3 on May 08, 2019
Recall Number Z-0597-2018
Recall Event ID 79067
510(K)Number K150600  
Product Classification Pedicle screw spinal system, adolescent idiopathic scoliosis - Product Code OSH
Product Response 5.5/6.0 Spine System 7.0mm x 40mm
Pedicle Screw

Product Usage:
Posterior non-cervical pedicle screw fixation
Code Information Model number: 00-1300-0740, Lot number: M82791-1
Recalling Firm/
Manufacturer		 OrthoPediatrics Corp
2850 Frontier Dr
Warsaw IN 46582-7001
For Additional Information Contact
574-268-6379
Manufacturer Reason
for Recall		 The 7mm diameter uniaxial pedicle screws have been color anodized with the same color utilized on 5 mm diameter screws.
FDA Determined
Cause 2		 Employee error
Action On August 4, 2017 an urgent medical device recall letter, titled "Response 5.5/6.0 Spine System - 7.0mm x 40mm UNIAXIAL PEDICLE SCREW" was issued to customers with instruction to quarantine affected product, which will be returned to the recalling firm for destruction. Questions or concerns can be directed to logistics@orthopediatrics.com or calling (574) 268-3692
Quantity in Commerce 24 units
Distribution US Nationwide Distribution
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 = OSH and Original Applicant = ORTHOPEDIATRICS CORP.
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