Drug recall
Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A…
FDA recall event 84545 · Class II · Brasseler USA I Lp
Key facts
| Event ID | 84545 |
|---|---|
| Recall numbers | Z-0884-2020 |
| Recalling firm | Brasseler USA I Lp |
| Product type | Devices |
| Products | Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tubes were incorrectly… |
| Initiation date | Dec 11, 2019 |
| Report date | Feb 5, 2020 |
| Termination date | Feb 12, 2021 |
| City | Savannah |
| State | GA |
| Country | United States |
| FEI number | 3004949275 |
At a glance
- 1–9 Products in this recall
- 1–9 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: