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.
This recall has been terminated (originally issued December 5, 2022).
- Company
- Integrity Implants Inc.
- Recall Initiated
- August 3, 2022
- Posted
- December 5, 2022
- Terminated
- October 23, 2023
- Recall Number
- Z-0421-2023
- Quantity
- 50 screws
- Firm Location
- Palm Beach Gardens, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for intraoperative screw head separation at weld location.
Distribution
US distribution to California, Indiana, New York, Oklahoma, Washington DC
Lot / Code Info
Part/Model Number LS-N6SG6545; UDI: (01)00818613027815(10)10210067; Lot Number: 10210067
Root Cause
Under Investigation by firm
Action Taken
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.
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