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 tray replenishments. La
Check against the official notice below — it lists the full affected range.
Integrity Implants Inc. is recalling 1,369 LineSider Spinal System pedicle screws used in spinal fusion surgery. The screws, which range from 5.5mm to 6.5mm in diameter and various lengths, were distributed nationwide to hospitals and surgical centers in 15 states and Puerto Rico. The recall affects specific lot numbers manufactured between 2021 and 2022, identified by part numbers and UDI codes beginning with LS-N6MG.
The screws are being recalled because of a potential defect in the weld that joins the Upper Tulip Head component to the Lower Tulip Head component. If this weld separates, the Tulip Head could separate from the Screw Shank, potentially compromising the stability of the spinal fixation system. The recall record does not specify what action affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank.
Reason for recall: Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the Tulip Head from the Screw Shank. Distribution: Nationwide distribution to AZ, CA, CT, DC, FL, IL, IN, LA, MA, MN, NJ, OK, PR, TN, TX, VA. Quantity: 1,369 screws Lot/code info: 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, Lot Number: 10200056. e. 6.5mm x 35mm, Part Number: LS-N6MG6535, UDI: (01)00818613028973(10)02210097, lot Number: 2210097; UDI: (01)00818613028973(10)10200057, Lot Number: 10200057; UDI: (01)00818613028973(10)10200057-1, Lot Number: 10200057-1. f. 6.5mm x 40mm, Part Number: LS-N6MG6540, UDI: (01)00818613028980(10)02210098, lot Number: 2210098; UDI: (01)00818613028980(10)10200058, Lot Number: 10200058; UDI: (01)00818613028980(10)10200058-1, Lot Number: 10200058-1. g. 6.5mm x 45mm, Part Number: LS-N6MG6545, UDI: (01)00818613028997(10)02210099, lot Number: 2210099; UDI: (01)00818613028997(10)10200059, Lot Number: 10200059; UDI: (01)00818613028997(10)10200059-1, Lot Number: 10200059-1. h. 6.5mm x 50mm, Part Number: LS-N6MG6550, UDI: (01)008181613029000(10)02210100, lot Number: 2210100; UDI: (01)00818613029000(10)10200060, Lot Number: 10200060; UDI: (01)00818613029000(10)102
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.