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.
FDA Recall Z-0421-2023 · Posted 2022-12-05
Advertisement
Recalling FirmIntegrity Implants Inc.
Recall StatusTerminated
Product CodeNKB
Date Initiated2022-08-03
Date Terminated2023-10-23
Product Quantity50 screws
Reason for Recall
Potential for intraoperative screw head separation at weld location.
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.
Root Cause
Under Investigation by firm
Distribution Pattern
US distribution to California, Indiana, New York, Oklahoma, Washington DC
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement