Device recall
Z-0948-2017: GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated…
FDA device recall · Class II · Tepha Incorporated
Key facts
| Recall number (Z-number) | Z-0948-2017 |
|---|---|
| Recall event | 75827 |
| Product | GalaSHAPE 3D; product code SH3D03, a medium size oval GalaSHAPE" 3D is indicated for use as a bioresorbable scaffold for soft tissue support and to repair, elevate and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome… |
| Product code | OOD |
| Recalling firm | Tepha Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 5, 2017 |
| 510(k) numbers | K161092 |
| FEI number | 3005670760 |
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