Device recall
Z-1149-2020: Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated…
FDA device recall · Class II · Blue Ortho
Key facts
| Recall number (Z-number) | Z-1149-2020 |
|---|---|
| Recall event | 84713 |
| Product | Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002 |
| Product code | OLO |
| Recalling firm | Blue Ortho |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 23, 2020 |
| 510(k) numbers | K152764 |
| FEI number | 3008027912 |
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