Product Wiki · Recalls · U.S. FDA — Device Enforcement

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 fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.

U.S. FDA — Device Enforcement · Germany · 2015-07-16 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2261-2015
Date of alert
2015-07-16
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Otto Bock Healthcare GmbH
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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