Device recall
Z-2070-2017: Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant…
FDA device recall · Class II · Mentor Texas, LP.
Key facts
| Recall number (Z-number) | Z-2070-2017 |
|---|---|
| Recall event | 76868 |
| Product | Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048 |
| Product code | FWM |
| Recalling firm | Mentor Texas, LP. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 13, 2017 |
| PMA numbers | P990075 |
| FEI number | 1000118360 |
At a glance
- None 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