LineSider Spinal System pedicle screws — Class II medical device recall Z-0421-2023
Terminated recall by Integrity Implants Inc., reported 2022-12-14, distributed in CA, DC, IN, NY, OK, WA. Potential for intraoperative screw head separation at weld location.
| Recall number | Z-0421-2023 |
|---|---|
| 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 | 2022-08-03 |
| Classified | 2022-12-05 |
| Reported by FDA | 2022-12-14 |
| Terminated | 2023-10-23 |
| Distributed | CA, DC, IN, NY, OK, WA |
| Quantity | 50 screws |
| UPC / GTIN / UDI-DI | 00818613027815 |
| Lot numbers | 10210067 |
| Model numbers | LS-N6SG6545 |
Product
LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual Lead, Non-cannulated. Model Number LS-N6SG6545. 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. Used in spinal fixation surgery.
Reason for recall
Potential for intraoperative screw head separation at weld location.
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-0421-2023. 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.