Device recall
Z-0324-2016: SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the…
FDA device recall · Class II · Pega Medical Inc.
Key facts
| Recall number (Z-number) | Z-0324-2016 |
|---|---|
| Recall event | 72529 |
| Product | SCFE Driver (SCF-MLD273 & SCF-MLD265) instrument used for the insertion of the Free Gliding SCFE Screw System. This instrument is included in the Free Gliding SCFE Screw System instrument tray. This instrument is marked with the catalogue number and lot number. The Free-Gliding SCFE Screw System is… |
| Product code | HWC |
| Recalling firm | Pega Medical Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 16, 2016 |
| 510(k) numbers | K131591 |
| 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