Device recall
Z-0828-2015: RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument…
FDA device recall · Class II · Mako Surgical Corporation
Key facts
| Recall number (Z-number) | Z-0828-2015 |
|---|---|
| Recall event | 69465 |
| Product | RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery. |
| Product code | OLO |
| Recalling firm | Mako Surgical Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 3, 2016 |
| 510(k) numbers | K121064 |
| FEI number | 3005985723 |
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