The Recall Desk
HighFDA (Devices)·Z-0418-2023·Announced 2022-12-14

Spinal Implant Screws Recalled Due to Potential Weld Failure

LineSider Spinal System screws are recalled due to potential weld separation between components that could cause the Tulip Head to detach from the Screw Shank. The recall affects 1,227 screws distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This Class II recall involves a surgical implant with potential structural failure from weld separation. Since no injuries or hospitalizations have been reported, it qualifies as a risk-of-harm product where injury has not yet been reported, meeting the Score 3 (High) criterion.

Plain-English summary

The LineSider Spinal System is a thoracolumbosacral pedicle screw system used in spinal fixation surgery. Integrity Implants Inc. is recalling 1,227 screws in multiple sizes and configurations, distributed nationwide to healthcare facilities in Arizona, California, Connecticut, Washington D.C., Florida, Illinois, Indiana, Louisiana, Massachusetts, Minnesota, New Jersey, Oklahoma, Puerto Rico, Tennessee, Texas, and Virginia.

The screws are being recalled due to a potential defect in the weld that connects the Upper Tulip Head component to the Lower Tulip Head component. If this weld separates, the Tulip Head could detach from the Screw Shank.

Healthcare providers who have received these screws should review their inventory using the provided lot numbers and part numbers to identify affected units. Patients who may have received these implants should contact their healthcare provider to determine if they were affected. The FDA has classified this as a Class II recall. Additional information is available through the FDA's recall database using recall number Z-0418-2023.

The recalled product

Product
LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as non-sterile and shipped in protective sterilization trays. Screws can also be shipped individu
Manufacturer
Integrity Implants Inc.
Category
Medical Device — Spinal Fixation System
Hazard
Affected units
1,227

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • a. 5.5mm x 35mm
  • Part Number: LS-N6SA5535
  • UDI: (01)00818613027716(10)02210117
  • lot Number: 2210117
  • Part Number: LS-N6SA7545
  • UDI: (01)00818613027884(10)02210130
  • Lot Number: 2210130. b. 5.5mm x 40mm
  • Part Number: LS-N6SA5540
  • UDI: (01)00818613027723(10)02210118
  • Lot Number: 2210118. c. 5.5mm x 45mm
  • Part Number: LS-N6SA5545
  • UDI: (01)00818613027730(10)02210119
  • Lot Number: 2210119. d. 5.5mm x 50mm
  • Part Number: LS-N6SA5550
  • UDI: (01)00818613027747(10)02210120
  • Lot Number: 2210120. e. 5.5mm x 55mm
  • Part Number: LS-N6SA5555
  • UDI: (01)00818613027754(10)02210121
  • Lot Number: 2210121. f. 6.5mm x 35mm
  • Part Number: LS-N6SA6535

Distribution

Distributed nationwide across the United States.

The notice also names 16 states specifically:

Part of a larger recall action

This product is one of 3 recalled by Integrity Implants Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · Integrity Implants Inc.

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Same hazard · weld separation

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