Device recall
Z-0367-2022: MENTOR Saline-Filled Breast Implants are constructed from room temperature…
FDA device recall · Class II · Mentor Texas, LP.
Key facts
| Recall number (Z-number) | Z-0367-2022 |
|---|---|
| Recall event | 88868 |
| Product | MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer, made of polydimethylsiloxane. Surgeons inflate the silicone elastomer shell to the desired size with sterile isotonic saline before implantation. The implants are available with SILTEX Textured… |
| Product code | FWM |
| Recalling firm | Mentor Texas, LP. |
| Recall class | Class II |
| Status | Open, Classified |
| 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