Device recall
Z-2092-2015: Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies…
FDA device recall · Class II · Synthes, Inc.
Key facts
| Recall number (Z-number) | Z-2092-2015 |
|---|---|
| Recall event | 71366 |
| Product | Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis |
| Product code | HTO |
| Recalling firm | Synthes, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 18, 2016 |
| 510(k) numbers | K111437 |
| FEI number | 3005180112 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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