The Recall Desk
HighFDA (Devices)·Z-0419-2023·Announced 2022-12-14

LineSider Spinal System Screws Recalled for Potential Weld Separation

Integrity Implants is recalling 1,702 LineSider Spinal System pedicle screws due to potential weld separation between screw head components that could result in device failure.

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: FDA Class II medical device with potential for structural failure in a spinal implant system. This is a risk-of-harm product where weld separation could result in serious patient injury during or after surgery, though no injuries have been reported.

Plain-English summary

Integrity Implants Inc. is recalling 1,702 LineSider Spinal System pedicle screws and interlaminal fixation orthosis components. These screws are used in spinal fixation surgery and are sold non-sterile in protective sterilization trays or individually.

The recalled screws have a potential defect involving the weld between the Upper Tulip Head and Lower Tulip Head components. This weld may separate, causing the Tulip Head to separate from the Screw Shank. Such a failure could compromise the structural integrity of the spinal fixation system.

The affected screws were distributed nationwide to facilities in Arizona, California, Connecticut, Washington D.C., Florida, Illinois, Indiana, Louisiana, Massachusetts, Minnesota, New Jersey, Oklahoma, Puerto Rico, Tennessee, Texas, and Virginia. Multiple part numbers and lot numbers are involved, ranging from 5.5mm to 8.5mm diameter screws in various lengths.

Patients who have received these screws should contact their healthcare provider. Healthcare providers should stop distributing and using the affected screws and review the FDA recall notice for complete lot number and part number information.

The recalled product

Product
LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, 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 individually
Manufacturer
Integrity Implants Inc.
Category
Medical Device — Orthopedic Implant / Spinal Fixation
Hazard
  • weld-separation
  • structural-defect

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-N6SG5535
  • UDI: (01)00818613022568(10)02210139
  • lot Number: 2210139. b. 5.5mm x 40mm
  • Part Number: LS-N6SG5540
  • UDI: (01)00818613022575(10)02210140
  • Lot Number: 2210140. c. 5.5mm x 45mm
  • Part Number: LS-N6SG5545
  • UDI: ((01)00818613022582(10)02210141
  • Lot Number: 2210141. d. 5.5mm x 50mm
  • Part Number: LS-N6SG5550
  • UDI: (01)00818613022599(10)02210142
  • Lot Number: 2210142. e. 5.5mm x 55mm
  • Part Number: LS-N6SG5555
  • UDI: (01)00818613022605(10)02210143
  • Lot Number: 2210143. f. 6.5mm x 35mm
  • Part Number: LS-N6SG6535
  • UDI: (01)00818613022643(10)02210144
  • Lot Number: 2210144. g. 6.5mm x 40mm
  • Part Number: LS-N6SG6540

Distribution

Distributed nationwide across the United States.

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