Otto Bock Healthcare GmbH: Medical Device Recall in 2015 - (Recall #: Z-2261-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 16, 2015

Date Posted: August 5, 2015

Recall Number: Z-2261-2015

Event ID: 71715

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 which may result in a fall.

Status: Terminated

Product Quantity: 518 (439 US; 79 OUS)

Code Information:

The removal affects all devices manufactured and distributed since February 2014.

Distribution Pattern:

Worldwide Distribution: US (nationwide) and countries of: AU, BE, CN, CZ, IT, NL, and SK.

Voluntary or Mandated:

Voluntary: Firm initiated