Drug recall
TB-0545PC: THUNDERBEAT 5 mm, 45 em, Pistol Grip TB-0535PC: THUNDERBEAT 5 mm, 35 em, Pi stol Grip TB-0545IC…
FDA recall event 66407 · Class II · Olympus America Inc.
Key facts
| Event ID | 66407 |
|---|---|
| Recall numbers | Z-0432-2014 |
| Recalling firm | Olympus America Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Complaints of damage to various models of Thunderbeat Hand Instruments during surgical procedures, including cracking, breaking, or deformation of the components of the probe tip or jaw. |
| Initiation date | Sep 27, 2013 |
| Report date | Dec 11, 2013 |
| Termination date | Feb 2, 2015 |
| City | Center Valley |
| State | PA |
| Country | United States |
| FEI number | 2429304 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: