Device recall
Z-1362-2015: GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog…
FDA device recall · Class II · Pega Medical Inc.
Key facts
| Recall number (Z-number) | Z-1362-2015 |
|---|---|
| Recall event | 70630 |
| Product | GAP Nail 4.8mm (diameter size) of the GAP ENDO-EXO MEDULLARY SYSTEM. Catalog number GAP-N48-16; GAP-N48-18; GAP-N48-26; GAP-N48-28. Product Usage: The GAP Endo-Exo Medullary System is used for the treatment of fractures or correction of deformities in the femur, tibia and humerus of pediatric… |
| Product code | HSB |
| Recalling firm | Pega Medical Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 30, 2015 |
| 510(k) numbers | K111232 |
| FEI number | 3000327445 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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