Device recall
Z-1559-2020: Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547)…
FDA device recall · Class II · Intellijoint Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-1559-2020 |
|---|---|
| Recall event | 85016 |
| Product | Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system… |
| Product code | OLO |
| Recalling firm | Intellijoint Surgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 10, 2020 |
| 510(k) numbers | K191507 |
| FEI number | 3010822102 |
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