FDA Medical Device Recalls (openFDA)
Integrity Implants Inc.: LineSider 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 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. 5.5mm x 55mm; f. 6.5mm x 35mm; g. 6.5mm x 40mm; h. 6.5mm x 45mm; i. 6.5mm x 50mm; j. 6.5mm x 55mm; k. 6.5mm x 60mm; l. 7.5mm x 35mm; m. 7.5mm x 40mm; n. 7.5mm x 45mm; o. 7.5mm x 50mm; p. 7.5mm x 55mm; q. 7.5mm x 60mm; r. 8.5mm x 35mm; s. 8.5mm x 40mm; t. 8.5mm x 45mm; u. 8.5mm x 50mm; v.8.5mm x 55mm; w. 8.5mm x 60mm; Used in spinal fixation surgery.
- Recall number
- Z-0419-2023
- Recalling firm
- Integrity Implants Inc.
- Product
- LineSider 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 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. 5.5mm x 55mm; f. 6.5mm x 35mm; g. 6.5mm x 40mm; h. 6.5mm x 45mm; i. 6.5mm x 50mm; j. 6.5mm x 55mm; k. 6.5mm x 60mm; l. 7.5mm x 35mm; m. 7.5mm x 40mm; n. 7.5mm x 45mm; o. 7.5mm x 50mm; p. 7.5mm x 55mm; q. 7.5mm x 60mm; r. 8.5mm x 35mm; s. 8.5mm x 40mm; t. 8.5mm x 45mm; u. 8.5mm x 50mm; v.8.5mm x 55mm; w. 8.5mm x 60mm; 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
- 1,702 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-N6SG5535, UDI: (01)00818613022568(10)02210139, lot Number: 2210139. b. 5.5mm x 40mm, Part Number: LS-N6SG5540, UDI: (01)00818613022575(10)02210140, Lot Number: 2210140. c. 5.5mm x 45mm, Part Number: LS-N6SG5545, UDI: ((01)00818613022582(10)02210141, Lot Number: 2210141. d. 5.5mm x 50mm, Part Number: LS-N6SG5550, UDI: (01)00818613022599(10)02210142, Lot Number: 2210142. e. 5.5mm x 55mm, Part Number: LS-N6SG5555, UDI: (01)00818613022605(10)02210143, Lot Number: 2210143. f. 6.5mm x 35mm, Part Number: LS-N6SG6535, UDI: (01)00818613022643(10)02210144, Lot Number: 2210144. g. 6.5mm x 40mm, Part Number: LS-N6SG6540, UDI: (01)00818613022650(10)02210145, Lot Number: 2210145. h. 6.5mm x 45mm, Part Number: LS-N6SG6545, UDI: (01)00818613022667(10)02210146, Lot Number: 2210146, UDI: (01)00818613022667(10)02210146-1, Lot Number: 02210146-1. i. 6.5mm x 50mm, Part Number: LS-N6SG6550, UDI: (01)00818613022674(10)02210147, Lot Number: 2210147. j. 6.5mm x 55mm, Part Number: LS-N6SG6555, UDI: (01)00818613022681(10)02210148, Lot Number: 2210148. k. 6.5mm x 60mm, Part Number: LS-N6SG6560, UDI: (01)00818613022698(10)02210149, Lot Number: 2210149. l. 7.5mm x 35mm, Part Number: LS-N6SG7535, UDI: (01)00818613022711(10)02210150, Lot Number: 2210150. m. 7.5mm x 40mm, Part Number: LS-N6SG7540, UDI: (01)00818613022735(10)02210152, Lot Number: 2210151. n. 7.5mm x 45mm, Part Number: LS-N6SG7545, UDI: (01)00818613027891(10)02210131, Lot Number: 2210152. o. 7.5mm x 50mm, Part Number: LS-N6SG7550, UDI: (01)00818613022742(10)02210153, Lot Number: 2210153. p. 7.5mm x 55mm, Part Number: LS-N6SG7555, UDI: (01)00818613022759(10)02210154, Lot Number: 2210154. q. 7.5mm x 60mm, Part Number: LS-N6SG7560, UDI: (01)00818613022766(10)02210155, Lot Number: 2210155. r. 8.5mm x 35mm, Part Number: LS-N6SG8535, UDI: (01)00818613022780(10)02210156, Lot Number: 2210156. s. 8.5mm x 40mm, Part Number: LS-N6SG8540, UDI: (01)00818613022797(10)02210157, Lot Number: 2210157. t. 8.5mm x 45mm, Part Number: LS-N6SG8545, UDI: (01)00818613022803(10)02210158, Lot Number: 2210158. u. 8.5mm x 50mm, Part Number: LS-N6SG8550, UDI: (01)00818613022810(10)02210159, Lot Number: 2210159. v.8.5mm x 55mm, Part Number: LS-N6SG8555, UDI: (01)00818613022827(10)02210160, Lot Number: 2210160. w. 8.5mm x 60mm, Part Number: LS-N6SG8560, UDI: (01)00818613022834(10)02210161, Lot Number: 2210161.
- 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
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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