Device recall
Z-0852-2014: The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised…
FDA device recall · Class II · ACUTE Innovations, LLC
Key facts
| Recall number (Z-number) | Z-0852-2014 |
|---|---|
| Recall event | 67117 |
| Product | The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to stabilize rib fractures, fusions and osteotomies during the normal bone healing process. The plates are manufactured from titanium and the screws are manufactured from titanium alloy… |
| Product code | HRS |
| Recalling firm | ACUTE Innovations, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 13, 2014 |
| 510(k) numbers | K113318 |
| FEI number | 3005670412 |
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