Drug recall
Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container…
FDA recall event 80445 · Class II · Encore Medical, Lp
Key facts
| Event ID | 80445 |
|---|---|
| Recall numbers | Z-2600-2018 |
| Recalling firm | Encore Medical, Lp |
| Product type | Devices |
| Products | Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible. |
| Initiation date | Jun 26, 2018 |
| Report date | Aug 8, 2018 |
| Termination date | Aug 22, 2023 |
| City | Austin |
| State | TX |
| Country | United States |
| FEI number | 1000116912 |
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: