Device recall
Z-0219-2020: Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the…
FDA device recall · Class II · OrthoPediatrics Corp
Key facts
| Recall number (Z-number) | Z-0219-2020 |
|---|---|
| Recall event | 83884 |
| Product | Model No. 01-1503-0032 (Adolescent Nail Attachment Bolt). Component of the Pediatric Nailing Platform. Product Usage: an orthopedic implant system commonly referred to as an intramedullary fixation rod (product code HSB). The attachment bolts are one component of the surgical instruments within the… |
| Product code | HSB |
| Recalling firm | OrthoPediatrics Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 30, 2020 |
| 510(k) numbers | K172583 |
| 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