FDA-Device2015-08-05Class II
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.
Otto Bock Healthcare GmbH
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.
Sold states
Worldwide Distribution: US (nationwide) and countries of: AU, BE, CN, CZ, IT, NL, and SK.
Affected count
518 (439 US; 79 OUS)
Manufactured in
Max-Nader-Str. #15, N/A, Duderstadt, N/A, Germany
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 attachment to other components based on the patient need and physiology.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2261-2015Don't want to check this manually?
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