Recall Z-0420-2023 · NKB Thoracolumbosacral Pedicle Screw System
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.
| Date | Dec 5, 2022 (initiated Jan 27, 2022) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203367 | LineSider™ Spinal System Integrity Implants, Inc., Dec 3, 2020 |