LineSider Spinal System pedicle screws recall
LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. Thoracolumbosacral…
Why was LineSider Spinal System pedicle screws recalled?
Potential for intraoperative screw head separation at weld location.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part/Model Number LS-N6SG6545; UDI: (01)00818613027815(10)10210067; Lot Number: 10210067
- Product
- LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. Thoracolumbosacral…
- Recalling firm
- Integrity Implants Inc.
- Quantity
- 50 screws
- Distribution
- US distribution to California, Indiana, New York, Oklahoma, Washington DC
- Recall date
- December 14, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)