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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 systemsee related information
Date Initiated by FirmAugust 03, 2017
Create DateFebruary 14, 2018
Recall Status1 Terminated 3 on May 08, 2019
Recall NumberZ-0597-2018
Recall Event ID 79067
510(K)NumberK150600 
Product Classification Pedicle screw spinal system, adolescent idiopathic scoliosis - Product Code OSH
ProductResponse 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
ActionOn 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 Commerce24 units
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OSH
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