Device recall
Z-0098-2014: Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead…
FDA device recall · Class II · Small Bone Innovations, Inc.
Key facts
| Recall number (Z-number) | Z-0098-2014 |
|---|---|
| Recall event | 66362 |
| Product | Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma Coated, rHead Recon… |
| Product code | KWI |
| Recalling firm | Small Bone Innovations, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 30, 2015 |
| 510(k) numbers | K002644, K010786, K011819, K982288 |
| FEI number | 3003640913 |
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