Integrity Implants Inc.: 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.

Recall number

Z-0420-2023

Recalling firm

Integrity Implants Inc.

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.

Status

Terminated

Initiated

2022-01-27

Posted

2022-12-05

Terminated

2023-10-23

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.

Root cause

Device Design

Action

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.

Quantity

1,369 screws

Distribution

Nationwide distribution to AZ, CA, CT, DC, FL, IL, IN, LA, MA, MN, NJ, OK, PR, TN, TX, VA.

Lot, serial or model codes

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.

510(k) numbers

["K203367"]

PMA numbers

not on file

Product code

NKB

Firm FEI

3012797630

Firm city

Palm Beach Gardens

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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