Device recall
Z-0155-2017: Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324…
FDA device recall · Class II · Windstone Medical Packaging, Inc.
Key facts
| Recall number (Z-number) | Z-0155-2017 |
|---|---|
| Recall event | 71968 |
| Product | Breast Augmentation Pack, Kit part number AMS1786, AMS1786(A, AMS2790, AMS3324, AMS3324(A, and PSS3430. convenience custom kits used for general surgery in hospital operating room |
| Product code | FSY |
| Recalling firm | Windstone Medical Packaging, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 25, 2016 |
| FEI number | 1000125955 |
At a glance
- None Linked 510(k)s
- 100–999 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