LineSider Spinal System 5 — Class II medical device recall Z-0418-2023
Terminated recall by Integrity Implants Inc., reported 2022-12-14, distributed nationwide. Potential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which wou
| Recall number | Z-0418-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integrity Implants Inc., Palm Beach Gardens, FL, United States |
| Recall initiated | 2022-01-27 |
| Classified | 2022-12-05 |
| Reported by FDA | 2022-12-14 |
| Terminated | 2023-10-23 |
| Distributed | Nationwide (US) |
| Quantity | 1,227 screws |
| UPC / GTIN / UDI-DI | 00818613027716, 00818613027723, 00818613027730, 00818613027747, 00818613027754, 00818613027792, 00818613027808, 00818613027815, 00818613027822, 00818613027839, 00818613027846, 00818613027860, 00818613027877, 00818613027884, 00818613027891, 00818613027907, 00818613027914, 00818613027938, 00818613027945, 00818613027952, 00818613027969, 00818613027976, 00818613027983 |
| Lot numbers | 2210117, 2210118, 2210119, 2210120, 2210121, 2210122, 2210123, 2210124, 2210125, 2210126, 2210127, 2210128, 2210129, 2210130, 2210131, 2210132, 2210133, 2210134, 2210135, 2210136, 2210137, 2210138, 3210142, 35MM, 40MM, 45MM, 5.5MM, 50MM, 55MM, 6.5MM, 60MM, 7.5MM, 8.5MM, U.8.5MM |
| Model numbers | LS-N6SA5535, LS-N6SA5540, LS-N6SA5545, LS-N6SA5550, LS-N6SA5555, LS-N6SA6535, LS-N6SA6540, LS-N6SA6545, LS-N6SA6550, LS-N6SA6555, LS-N6SA6560, LS-N6SA7535, LS-N6SA7540, LS-N6SA7545, LS-N6SA7550, LS-N6SA7555, LS-N6SA7560, LS-N6SA8535, LS-N6SA8540, LS-N6SA8545, LS-N6SA8550, LS-N6SA8555, LS-N6SA8560 |
Product
LineSider Spinal System 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-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 50mm; o. 7.5mm x 55mm; p. 7.5mm x 60mm; q. 8.5mm x 35mm; r. 8.5mm x 40mm; s. 8.5mm x 45mm; t. 8.5mm x 50mm; u.8.5mm x 55mm; v. 8.5mm x 60mm; Used in spinal fixation surgery.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0418-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.