The Recall Desk
HighFDA (Devices)·Z-0420-2023·Announced 2022-12-14

Spinal implant screws recalled for potential weld separation

Integrity Implants recalls 1,369 spinal implant screws due to potential weld separation between components. No injuries have been reported.

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 is a risk-of-harm product (spinal implant) with theoretical hazard (potential weld separation) and no reported injuries or illnesses, which per the rubric merits a score of 3 (High). While classified as FDA Class II, the absence of reported hospitalizations or injuries caps the severity at 3.

Plain-English summary

Integrity Implants Inc. is recalling 1,369 LineSider Spinal System pedicle screws used in spinal fixation surgery. The recalled screws are available in sizes ranging from 5.5mm to 9.5mm in diameter and 35mm to 55mm in length.

The screws are subject to recall because of a potential for weld separation between the Upper Tulip Head component and the Lower Tulip Head component. If this separation occurs, the Tulip Head could separate from the Screw Shank.

The recalled screws were distributed to medical facilities in Arizona, California, Connecticut, the District of Columbia, Florida, Illinois, Indiana, Louisiana, Massachusetts, Minnesota, New Jersey, Oklahoma, Puerto Rico, Tennessee, Texas, and Virginia. Each size and lot number is identified in the recall notice.

Healthcare providers should identify affected inventory using the provided lot and part numbers and contact Integrity Implants Inc. for guidance. Patients who have received these implants should consult their surgeon if they have concerns about their implant.

The recalled product

Product
LineSider Spinal System 5.5/6.0mm, Non-mod MIS 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, as
Manufacturer
Integrity Implants Inc.
Category
Medical Device — Spinal Implants
Hazard
  • weld-separation
  • implant-failure

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-N6MG5535
  • UDI: (01)00818613028898(10)02210093
  • lot Number: 2210093
  • UDI: (01)00818613028898(10)10200053
  • Lot Number: 10200053. b. 5.5mm x 40mm
  • Part Number: LS-N6MG5540
  • UDI: (01)00818613028904(10)02210094
  • lot Number: 2210094
  • UDI: (01)00818613028904(10)10200054
  • Lot Number: 10200054. c. 5.5mm x 45mm
  • Part Number: LS-N6MG5545
  • UDI: (01)00818613028911(10)02210095
  • lot Number: 2210095
  • UDI: (01)00818613028911(10)10200055
  • Lot Number: 10200055. d. 5.5mm x 50mm
  • Part Number: LS-N6MG5550
  • UDI: (01)00818613028928(10)02210096
  • lot Number: 2210096
  • UDI: (01)00818613028928(10)10200056

Distribution

Distributed nationwide across the United States.

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