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/ Manufacturer |
Integrity Implants Inc. 354 Hiatt Drive Palm Beach Gardens FL 33418
|
For Additional Information Contact |
Integrity 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 |
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
|
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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.
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