LineSider recallZ-0420-2023 · Integrity Implants Inc. · initiated Jan 27, 2022
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Integrity Implants Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
Integrity Implants notified consignees on 01/28/2022, via emailed letter. The letter instructed consignees to quarantine affected product, complete and return the Product Tracking & Verification Form, and return affected product. On 02/05/2022 the recall was expanded, and consignees were notified via emailed letter. The listed the additional affected product and contained the same instructions to consignees.
Recall details
- Recall number
- Z-0420-2023
- Status
- Terminated
- Initiated by the company
- Jan 27, 2022
- Posted by the FDA
- Dec 5, 2022
- Recalling firm
- Integrity Implants Inc.
- Quantity
- 1,369 screws
- Product code
- NKB
- FDA submissions
- K203367
- Distribution
- Nationwide distribution to AZ, CA, CT, DC, FL, IL, IN, LA, MA, MN, NJ, OK, PR, TN, TX, VA.
Product 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.
Code information (models, lots, serial numbers)
Show the full code information (4k characters)
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.
Devices named in this recall
24 devices in the FDA device registry whose identifier appears in the recall's code information.
- LineSider LS-N6MG7545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall2 reports
- LineSider LS-N6MG7535Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG7540Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG7555Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG8535Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG8540Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG8545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG8550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG8555Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG9535Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG9540Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG9545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG9550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG9555Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG5535Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG5540Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG5545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG5550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG6535Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG6540Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG6550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6MG6555Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
Product lines
Other devices under the same FDA submission
45 devices cleared under K203367 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- LineSider LS-N6SA7550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls1 report
- LineSider LS-N6SA6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System2 recalls0 reports
- LineSider LS-N6SG6550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall1 report
- LineSider LS-N6SG7545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall1 report
- LineSider LS-N6SG5535Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG5540Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG5545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG5550Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG5555Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG6535Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG6540Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
- LineSider LS-N6SG6545Integrity Implants Inc. · Thoracolumbosacral Pedicle Screw System1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 91070).
- Z-0418-2023 · TerminatedLineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sol…
- Z-0419-2023 · TerminatedLineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Cannulated. Thoracolumbosacral pedicle screw system; Spinal interlaminal fixation orthosis. Product sold as…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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