Recall Z-0421-2023— Integrity Implants Inc.
Class II · Terminated
Class II FDA medical device recall by Integrity Implants Inc., initiated 2022-08-03, terminated 2023-10-23. It names one FDA 510(k) clearance: K203367. 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.. Reason: Potential for intraoperative screw head separation at weld location..
- Recalling firm
- Integrity Implants Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-08-03
- Terminated
- 2023-10-23
- Firm location
- Palm Beach Gardens, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.