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U.S. Department of Health and Human Services

Class 2 Device Recall LineSider Spinal System

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  Class 2 Device Recall LineSider Spinal System see related information
Date Initiated by Firm August 03, 2022
Date Posted December 05, 2022
Recall Status1 Terminated 3 on October 23, 2023
Recall Number Z-0421-2023
Recall Event ID 91071
510(K)Number K203367  
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
Product LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545.

Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individually, as tray replenishments.

Used in spinal fixation surgery.
Code Information Part/Model Number LS-N6SG6545; UDI: (01)00818613027815(10)10210067; Lot Number: 10210067
Recalling Firm/
Integrity Implants Inc.
354 Hiatt Drive
Palm Beach Gardens FL 33418
For Additional Information Contact Integrity Implants Customer Service
Manufacturer Reason
for Recall
Potential for intraoperative screw head separation at weld location.
FDA Determined
Cause 2
Under Investigation by firm
Action Integrity Implants notified consignees on about 08/03/2022 via emailed letter. The letter instructed consignees to examine inventory and quarantine any affected product, arrange for the return of affected products, and complete and return the response form.
Quantity in Commerce 50 screws
Distribution US distribution to California, Indiana, New York, Oklahoma, Washington DC
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 = NKB and Original Applicant = Integrity Implants Inc.