FDA Device recall Z-2261-2015
Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic f…
- FDA Device
- Class II
- terminated
- Published 2015-08-05
On 2015-08-05 the FDA classified a Class II recall of Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic f… by Otto Bock Healthcare, citing 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 ce….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2261-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-16 |
| Published | 2015-08-05 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Otto Bock Healthcare |
| Distribution | US |
Product
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 attachment to other components based on the patient need and physiology.
Reason
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 which may result in a fall.
Identifiers
| code_info | The removal affects all devices manufactured and distributed since February 2014. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2261-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.