Drug recall
TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
FDA recall event 79636 · Class II · Integra LifeSciences Corp.
Key facts
| Event ID | 79636 |
|---|---|
| Recall numbers | Z-1487-2018 |
| Recalling firm | Integra LifeSciences Corp. |
| Product type | Devices |
| Products | TCC-EZ, Total Contact Cast System, Model No. TCC2-4051 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A quarantined lot of the devices was released for sale. Devices from this lot may experience increased exothermic reaction causing higher levels of heat output which exceed the product specifications. |
| Initiation date | Aug 18, 2017 |
| Report date | May 2, 2018 |
| Termination date | Jul 19, 2018 |
| City | Plainsboro |
| State | NJ |
| Country | United States |
| FEI number | 3003418325 |
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: