Device recall
Z-0421-2023: LineSider Spinal System pedicle screws, 5.5/6.0mm, Non-mod Standard 7.1mm - Dual…
FDA device recall · Class II · Integrity Implants Inc.
Key facts
| Recall number (Z-number) | Z-0421-2023 |
|---|---|
| Recall event | 91071 |
| 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… |
| Product code | NKB |
| Recalling firm | Integrity Implants Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 23, 2023 |
| 510(k) numbers | K203367 |
| FEI number | 3012797630 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database