Drug recall
OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur)
FDA recall event 86526 · Class II · Merete Medical GmbH
Key facts
| Event ID | 86526 |
|---|---|
| Recall numbers | Z-0435-2021, Z-0436-2021, Z-0437-2021, Z-0438-2021 |
| Recalling firm | Merete Medical GmbH |
| Product type | Devices |
| Products | OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (femur), OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (humerus), OsteoBridge Intramedullary Diaphysis Segment Fixation (IDSF) nails (tibia), OsteoBridge Intremedullary Knee Arthrodesis (IKA) nails |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product may be mislabeled. |
| Initiation date | Sep 18, 2020 |
| Report date | Nov 18, 2020 |
| Termination date | May 13, 2021 |
| City | Berlin |
| Country | Germany |
| FEI number | 3002949614 |
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: