Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lowe

FDA device recall Z-2261-2015 · posted 2015-07-24 · Terminated

Recall details

Recalling firm

Otto Bock Healthcare GmbH

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.

Action taken

The firm, Ottobock, sent an "URGENT MEDICAL DEVICE RECALL 3R62 Pheon" letter dated 16 July 2015 to its customers. The letter described the product, problem, and actions to be taken. The customers instructed to read this notice in its entirety; examine your stock for 3R62 Pheon devices; quarantine 3R62 Pheon devices and prevent further distribution; contact Ottobock customer service at (800) 328-4058-option 1 or (512) 806-2000 -Option 1, to obtain a return authorization for those devices, and complete and return the MEDICAL DEVICE RECALL RETURN RESPONSE Acknowledgement and Receipt Form via email to: USRecalls@ottobock.com "Pheon Recall"; fax (801) 974-6718-"Pheon Recall" or mail to: Otto Bock HealthCare LP, ATTN: PHEON RECALL, 3820 W. Great Lakes Drive, Salt Lake City, UT 84120-B7 is re-designing the locking function to prevent this failure from occurring. The re-designed devices will be available for replacement sometime within the next few months. If you have any questions contact Director, Regulatory & Quality Compliance at (801) 974-6618 or email: Lex.Pearce@ottobock.com.

Root cause

Component design/selection

Status

Terminated

Product code

ISY

Quantity affected

518 (439 US; 79 OUS)

Distribution

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

Date initiated

2015-07-16

Date posted

2015-07-24

Date terminated

2017-06-21

Location

Duderstadt, Germany