Device recall
Z-2201-2015: iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count…
FDA device recall · Class II · Myoscience Inc
Key facts
| Recall number (Z-number) | Z-2201-2015 |
|---|---|
| Recall event | 71650 |
| Product | iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually packaged in Tyvek PET pouches, which are then packaged into 5 or 10 pack boxes and shipper boxes. Product Usage: Cyrogenic Surgical Device The myoscience iovera device is… |
| Product code | GXH |
| Recalling firm | Myoscience Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 8, 2015 |
| 510(k) numbers | K142866 |
| FEI number | 3009131456 |
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