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Otto Bock Healthcare GmbH recalls Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for l
Recalled August 5, 2015 · FDA recall Z-2261-2015 · Otto Bock Healthcare
Hazard
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. · FDA Class II
Units
518 (439 US; 79 OUS)
Sold at
Worldwide Distribution: US (nationwide) and countries of: AU, BE, CN, CZ, IT, NL, and SK.
Description
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.
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.
Manufacturer(s)
Otto Bock Healthcare GmbH
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →