Device recall
Z-1986-2019: Erisma- LP posterior fixation system with the below specifically affected…
FDA device recall · Class III · Clariance Inc
Key facts
| Recall number (Z-number) | Z-1986-2019 |
|---|---|
| Recall event | 83218 |
| Product | Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4. Erisma-LPT20 Snap Fit Tightening Wrench |
| Product code | NKB |
| Recalling firm | Clariance Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 9, 2020 |
| 510(k) numbers | K153326 |
| FEI number | 3009962553 |
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