Drug recall
Human Tendon
FDA recall event 78200 · Class II · RTI Surgical, Inc.
Key facts
| Event ID | 78200 |
|---|---|
| Recall numbers | B-0003-2018 |
| Recalling firm | RTI Surgical, Inc. |
| Product type | Biologics |
| Products | Human Tendon |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Human tissue allograft, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease… |
| Initiation date | Sep 19, 2017 |
| Report date | Oct 11, 2017 |
| Termination date | Oct 3, 2017 |
| City | Alachua |
| State | FL |
| Country | United States |
| FEI number | 3002719998 |
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: