Device recall
Z-0622-2016: UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0…
FDA device recall · Class II · OrthoPediatrics Corp
Key facts
| Recall number (Z-number) | Z-0622-2016 |
|---|---|
| Recall event | 72962 |
| Product | UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The Response 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as… |
| Product code | NKB |
| Recalling firm | OrthoPediatrics Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 23, 2016 |
| 510(k) numbers | K150600 |
| FEI number | 3006460162 |
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