--- title: "LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated.... — FDA record Z-0420-2023 | Is It on Recall" description: "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" url: https://isitonrecall.com/recall/fda-device-z-0420-2023-linesider-spinal-system-5-5-6-0mm-non-mod-mis-7-1mm-dual-lead-cannulated-thoracolumbosacral-pedicle/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # LineSider Spinal System 5.5/6.0mm, Non-mod MIS 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system... — FDA record Z-0420-2023 Reported terminated Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Jan 27, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **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 tray replenishments. Labeled as the following sizes: a. 5.5mm x 35mm; b. 5.5mm x 40mm; c. 5.5mm x 45mm; d. 5.5mm x 50mm; e. 6.5mm x 35mm; f. 6.5mm x 40mm; g. 6.5mm x 45mm; h. 6.5mm x 50mm; i. 6.5mm x 55mm; j. 7.5mm x 35mm; k. 7.5mm x 40mm; l. 7.5mm x 45mm; m. 7.5mm x 50mm; n. 7.5mm x 55mm; o. 8.5mm x 35mm; p. 8.5mm x 40mm; q. 8.5mm x 45mm; r. 8.5mm x 50mm; s.8.5mm x 55mm; t. 9.5mm x 35mm; u. 9.5mm x 40mm; v. 9.5mm x 45mm; w. 9.5mm x 50mm; x. 9.5mm x 55mm; Used in spinal fixation surgery. - **Reason**: 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. - **Classification**: Class II - **Recalling firm**: Integrity Implants Inc. - **Quantity**: 1,369 screws - **Agency-reported status**: Terminated - **Source record identifier**: Z-0420-2023 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0420-2023%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 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)10200060-1, Lot Number: 10200060-1. i. 6.5mm x 55mm, Part Number: LS-N6MG6555, UDI: (01)00818613029017(10)02210101, lot Number: 2210101; UDI: (01)00818613029017(10)10200061, Lot Number: 10200061. j. 7.5mm x 35mm, Part Number: LS-N6MG7535, UDI: (01)00818613026528(10)02210102, lot Number: 2210102; UDI: (01)00818613026528(10)10200062, Lot Number: 10200062. k. 7.5mm x 40mm, Part Number: LS-N6MG7540, UDI: (01)00818613026535(10)02210103, lot Number: 2210103; UDI: (01)00818613026535(10)10200063, Lot Number: 10200063; UDI: (01)00818613026535(10)06210309, Lot Number: 6210309. l. 7.5mm x 45mm, Part Number: LS-N6MG7545, UDI: (01)00818613026542(10)02210104, lot Number: 2210104; UDI: (01)00818613026542(10)10200064, Lot Number: 10200064; UDI: (01)00818613026542(10)10200064-1, Lot Number: 10200064-1. m. 7.5mm x 50mm, Part Number: LS-N6MG7550, UDI: (01)00818613026559(10)02210105, lot Number: 2210105; UDI: (01)00818613026559(10)10200065, Lot Number: 10200065; UDI: (01)00818613026559(10)10200065-1, Lot Number: 10200065-1. n. 7.5mm x 55mm, Part Number: LS-N6MG7555, UDI: (01)00818613026566(10)02210106, lot Number: 2210106; UDI: (01)00818613026566(10)10200066, Lot Number: 10200066. o. 8.5mm x 35mm, Part Number: LS-N6MG8535, UDI: (01)00818613026597(10)02210107, lot Number: 2210107; UDI: (01)00818613026597(10)10200067, Lot Number: 10200067. p. 8.5mm x 40mm, Part Number: LS-N6MG8540, UDI: (01)00818613026603(10)02210108, lot Number: 2210108; UDI: (01)00818613026603(10)10200068, Lot Number: 10200068. q. 8.5mm x 45mm, Part Number: LS-N6MG8545, UDI: (01)00818613026610(10)02210109, lot Number: 2210109; UDI: (01)00818613026610(10)10200069, Lot Number: 10200069. r. 8.5mm x 50mm, Part Number: LS-N6MG8550, UDI: (01)00818613026627(10)02210110, lot Number: 2210110; UDI: (01)00818613026627(10)10200070, Lot Number: 10200070. s. 8.5mm x 55mm, Part Number: LS-N6MG8555, UDI: (01)00818613026634(10)02210111, lot Number: 2210111; UDI: (01)00818613026634(10)10200071, Lot Number: 10200071. t. 9.5mm x 35mm, Part Number: LS-N6MG9535, UDI: (01)00818613026658(10)02210112, lot Number: 2210112; UDI: (01)00818613026658(10)10200072, Lot Number: 10200072. u. 9.5mm x 40mm, Part Number: LS-N6MG9540, UDI: (01)00818613026665(10)02210113, lot Number: 2210113; UDI: (01)00818613026665(10)10200073, Lot Number: 10200073. v. 9.5mm x 45mm, Part Number: LS-N6MG9545, UDI: (01)00818613026672(10)02210114, lot Number: 2210114; UDI: (01)00818613026672(10)10200074, Lot Number: 10200074. w. 9.5mm x 50mm, Part Number: LS-N6MG9550, UDI: (01)00818613026689(10)02210115, lot Number: 2210115; UDI: (01)00818613026689(10)10200075, Lot Number: 10200075. x. 9.5mm x 55mm, Part Number: LS-N6MG9555, UDI: (01)00818613026696(10)02210116, lot Number: 2210116; UDI: (01)00818613026696(10)10200076, Lot Number: 10200076. | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Nationwide distribution to AZ, CA, CT, DC, FL, IL, IN, LA, MA, MN, NJ, OK, PR, TN, TX, VA. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Dec 14, 2022 - **Recall initiation date**: Jan 27, 2022 - **Center classification date**: Dec 5, 2022 - **Termination date**: Oct 23, 2023 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0420-2023%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Integrity Implants Inc. records](https://isitonrecall.com/brand/integrity-implants-inc/)