Drug recall
AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed…
FDA recall event 79147 · Class II · Howmedica Osteonics Corp.
Key facts
| Event ID | 79147 |
|---|---|
| Recall numbers | Z-0810-2018 |
| Recalling firm | Howmedica Osteonics Corp. |
| Product type | Devices |
| Products | AccuLIF TL Insertion Handle The AccuLIF Insertion Handle attaches to the implant and is specifically designed to allow a surgeon to insert the implant into the disc space with a fixed engagement… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | When the lever of the Insertion Handle is in the "locked" position, the implant may be able to pivot rather than maintaining a rigid connection. |
| Initiation date | Sep 8, 2017 |
| Report date | Mar 7, 2018 |
| Termination date | Jul 31, 2018 |
| City | Allendale |
| State | NJ |
| Country | United States |
| FEI number | 3004024955 |
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: