Device recall
Z-0432-2014: TB-0545PC: THUNDERBEAT 5 mm, 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35…
FDA device recall · Class II · Olympus America Inc.
Key facts
| Recall number (Z-number) | Z-0432-2014 |
|---|---|
| Recall event | 66407 |
| Product | TB-0545PC: THUNDERBEAT 5 mm , 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC: THUNDERBEAT 5 mm, 45 em, In line Grip TB-0535IC: THUNDERBEAT 5 mm, 35 em, Inline Grip TB-0520IC: THUNDERBEAT 5 mm, 20 em, In line Grip TB-051 OIC: THUNDERBEAT 5 mm, I 0 em, In line Grip… |
| Product code | GEI |
| Recalling firm | Olympus America Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 2, 2015 |
| 510(k) numbers | K111202 |
| FEI number | 2429304 |
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