Device recall
Z-1374-2018: Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM…
FDA device recall · Class II · Tornier, Inc
Key facts
| Recall number (Z-number) | Z-1374-2018 |
|---|---|
| Recall event | 79373 |
| Product | Fornier Phantom Fiber(TM) Sutures: Item Number Description SMB000425 4.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMB000525 5.5 MM PHANTOM FT BIOCOMPOSITE SUTURE ANCHOR WITH NEEDLES SMP000425 4.5 MM PHANTOM FT PEEK SUTURE ANCHOR WITH NEEDLES SMP000525 5.5 MM PHANTOM FT PEEK SUTURE… |
| Product code | NWJ |
| Recalling firm | Tornier, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 7, 2020 |
| 510(k) numbers | K130422 |
| FEI number | 3000718467 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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