Recall Z-0421-2023
Integrity Implants Inc. · initiated August 3, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Part/Model Number LS-N6SG6545; UDI: (01)00818613027815(10)10210067; Lot Number: 10210067
Reason for recall
Potential for intraoperative screw head separation at weld location.
FDA-determined 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.
Details
- Recall number
- Z-0421-2023
- Initiated
- August 3, 2022
- Posted by FDA
- December 5, 2022
- Terminated
- October 23, 2023
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- Quantity
- 50 screws
- Distribution
- US distribution to California, Indiana, New York, Oklahoma, Washington DC
- Recalling firm
- Integrity Implants Inc., Palm Beach Gardens, FL