Device recall
Z-1916-2015: Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI…
FDA device recall · Class II · RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Key facts
| Recall number (Z-number) | Z-1916-2015 |
|---|---|
| Recall event | 71424 |
| Product | Bullet-Tip PEEK VBR/IBF System, 32mm(l) 13mm(H) Implant 32-13-32 UDI (01)008464680341 08(17)191218(10)200827; T-Plus PEEK VBR/IBF System, 10mm(W) x 27mm(l) x 13mm(H) Implant, 6degree lordotic 30-T-13-6 UDI (01) 00846468032920(17) 200116(10) 202726; and T-Plus PEEK VBR/IBF System, 10mm(W) x 36 mm(l)… |
| Product code | MAX |
| Recalling firm | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 29, 2015 |
| 510(k) numbers | K133455 |
| FEI number | 1000115331 |
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