The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0421-2023·Announced 2022-12-14

Spinal pedicle screws recalled for potential intraoperative screw head separation

Integrity Implants Inc. is recalling LineSider Spinal System pedicle screws (Model LS-N6SG6545) due to potential screw head separation at the weld location during surgery. This Class II recall affects units distributed to California, Indiana, New York, Oklahoma, and Washington DC.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 serious structural failure (screw head separation) during surgical implantation. No illnesses or injuries reported. Classified as a risk-of-harm product where injury has not yet been reported, meeting the criteria for High severity.

Plain-English summary

The FDA has issued a Class II recall of LineSider Spinal System pedicle screws (Model LS-N6SG6545), manufactured by Integrity Implants Inc. These pedicle screws are used in spinal fixation surgery to stabilize the spine. The screws have been identified as having a potential defect at the weld location that connects the screw head to the shaft. Under intraoperative conditions, the screw head may separate from the shaft during spinal fixation surgery.

The recall affects 50 screws from Lot Number 10210067. These units were distributed in the United States to hospitals and medical facilities in California, Indiana, New York, Oklahoma, and Washington DC. The screws were sold as non-sterile products and shipped in protective sterilization trays.

No illnesses or injuries have been reported to date. However, screw head separation during spinal fixation surgery could result in serious intraoperative complications and may require additional surgical intervention.

Healthcare providers and facilities that have received these screws should contact Integrity Implants Inc. immediately for instructions. Affected patients who have received or are scheduled to receive these screws should consult with their healthcare provider regarding this recall.

The recalled product

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…
Manufacturer
Integrity Implants Inc.
Category
Medical Device — Spinal Fixation Device
Hazard
Affected units
50

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 (3)

  • Part/Model Number LS-N6SG6545
  • UDI: (01)00818613027815(10)10210067
  • Lot Number: 10210067

Distribution

Distributed in 5 states:

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