The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Ar

FDA device recall Z-1322-2015 · posted 2015-03-25 · Terminated

Recall details

Recalling firm

Ossur H / F

Reason for recall

The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully going through the assembly process.

Action taken

The firm, Ossur, notified their customers of the Recall Notice via phone on February 26, 2015. The firm informed the customers about the recalled product, the problem and actions to be taken. The customers were instructed to send the unit in for service so the Acceptance testing can be performed for the unit in accordance to their process. If you have any questions, please contact Regulatory Affairs & Quality Assurance specialist at 949-382-3741 or email: kmontes@ossur.com.

Root cause

Employee error

Status

Terminated

Product code

ISW

Quantity affected

4715 units (2 units affected)

Distribution

Worldwide distribution: US distribution in TN and country of: Austria.

Date initiated

2015-02-26

Date posted

2015-03-25

Date terminated

2015-11-20

Location

Reykjavik, Iceland