Device recall
Z-1718-2019: Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage…
FDA device recall · Class II · I.T.S. GmbH
Key facts
| Recall number (Z-number) | Z-1718-2019 |
|---|---|
| Recall event | 82796 |
| Product | Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed. |
| Product code | HRS |
| Recalling firm | I.T.S. GmbH |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K063166 |
| FEI number | 3004369035 |
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