Drug recall
Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P.
FDA recall event 83037 · Class II · Encore Medical, Lp
Key facts
| Event ID | 83037 |
|---|---|
| Recall numbers | Z-2090-2019 |
| Recalling firm | Encore Medical, Lp |
| Product type | Devices |
| Products | Flexible Drill Shaft, FMP Acetabular System Instrumentation REF 803-05-239 RX Encore Medical, L.P. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit shaft to capture the drill bit pin could result in the drill bit coming loose which… |
| Initiation date | Sep 19, 2018 |
| Report date | Aug 7, 2019 |
| 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: