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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Integrity Implants Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0420-2023
Related Recalls
Due to incompatibility of bone tamp (Rev A) and bone funnels (Rev C).
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.
Potential for intraoperative screw head separation at weld location.