Device recall
Z-1975-2021: PERLA TL Lateral Connector Open - Product Usage: intended to be used with…
FDA device recall · Class II · SPINEART SA
Key facts
| Recall number (Z-number) | Z-1975-2021 |
|---|---|
| Recall event | 87971 |
| Product | PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Models: PERLA TL Lateral Connector Open, 15mm PERLA TL Lateral Connector Open, 30mm |
| Product code | NKB |
| Recalling firm | SPINEART SA |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 29, 2022 |
| 510(k) numbers | K193396 |
| FEI number | 3007728266 |
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