Device recall
Z-2591-2014: EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use…
FDA device recall · Class II · Mentor Texas, LP.
Key facts
| Recall number (Z-number) | Z-2591-2014 |
|---|---|
| Recall event | 69022 |
| Product | EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted. |
| Product code | MRD |
| Recalling firm | Mentor Texas, LP. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 6, 2015 |
| 510(k) numbers | K010709 |
| FEI number | 1000118360 |
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