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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 Systemsee related information
Date Initiated by FirmAugust 03, 2022
Date PostedDecember 05, 2022
Recall Status1 Terminated 3 on October 23, 2023
Recall NumberZ-0421-2023
Recall Event ID 91071
510(K)NumberK203367 
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
ProductLineSider 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/
Manufacturer		 Integrity Implants Inc.
354 Hiatt Drive
Palm Beach Gardens FL 33418
For Additional Information ContactIntegrity Implants Customer Service
561-529-3861
Manufacturer Reason
for Recall		Potential for intraoperative screw head separation at weld location.
FDA Determined
Cause 2		Under Investigation by firm
ActionIntegrity 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 Commerce50 screws
DistributionUS distribution to California, Indiana, New York, Oklahoma, Washington DC
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 = NKB
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