Drug recall
Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used…
FDA recall event 71715 · Class II · Otto Bock Healthcare GmbH
Key facts
| Event ID | 71715 |
|---|---|
| Recall numbers | Z-2261-2015 |
| Recalling firm | Otto Bock Healthcare GmbH |
| Product type | Devices |
| Products | Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joints distributed since February 2014 because the locking function may fail under certain conditions… |
| Initiation date | Jul 16, 2015 |
| Report date | Aug 5, 2015 |
| Termination date | Jun 21, 2017 |
| City | Duderstadt |
| Country | Germany |
| FEI number | 3003117657 |
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: