Z-0421-2023 Class II Terminated
FDA device recall Z-0421-2023 was initiated by Integrity Implants Inc. on August 3, 2022 and is designated Class II. Reason for recall: Potential for intraoperative screw head separation at weld location. The recall status is terminated (terminated October 23, 2023). Affected quantity: 50 screws.
Recall Details
- Product Type
- Devices
- Report Date
- December 14, 2022
- Initiation Date
- August 3, 2022
- Termination Date
- October 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 screws
Product Description
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.
Reason for Recall
Potential for intraoperative screw head separation at weld location.
Distribution Pattern
US distribution to California, Indiana, New York, Oklahoma, Washington DC
Code Information
Part/Model Number LS-N6SG6545; UDI: (01)00818613027815(10)10210067; Lot Number: 10210067