Drug recall
SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument…
FDA recall event 84017 · Class II · Pega Medical Inc.
Key facts
| Event ID | 84017 |
|---|---|
| Recall numbers | Z-0270-2020 |
| Recalling firm | Pega Medical Inc. |
| Product type | Devices |
| Products | SCFE (slipped capital femoral epiphysis) Knobs for Driver, 6.5mm and 7.3 mm Orthopedic surgical instrument component, for hip surgery |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out. |
| Initiation date | Oct 2, 2019 |
| Report date | Nov 13, 2019 |
| Termination date | Oct 26, 2020 |
| City | Laval |
| Country | Canada |
| FEI number | 3000327445 |
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: