Total Knee Junior Model Number 1100 Product Usage: The Total Knee Junior is an external polycentric prosthetic knee with

FDA device recall Z-0965-2012 · posted 2012-02-06 · Terminated

Recall details

Recalling firm

Ossur H / F

Reason for recall

Some units of the Total Knee Junior produced between November 25th, 2008 and through April, 2009 contain balancing units that may fail under extreme use over a long period. The fault is noncritical and no incidents or injuries resulting from this situation have been reported to Ossur at this stage. Over long term use (estimated to be in the four to six year range) the prosthetic device may fail a

Action taken

Ossur sent a Safety Notice dated August 10, 2009 by mailed to all affected consignees. Ossur informed consignees of the above mentioned public reason for recall and asked consignees to take the following action: Identify the users of each of the Total Knee Junior model devices listed above and check inventory and isolate any recalled devices on hand but have not fitted on users. The letter states that Sue Fitzgerald from customer service will be contacting consignees in the next few days to coordinate replacement of the affected devices. For question call 1-(800) 219-2150, Ext: 4109. In addition, Ossur website: www.ossur.com we will be posting updates as appropriate.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

ISY

Quantity affected

141 units

Distribution

Worldwide Distribution - USA (nationwide) in the state of: AL, AR, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, and WV and the countries of: Aust

Date initiated

2009-08-10

Date posted

2012-02-06

Date terminated

2012-02-06

Location

Reykjavik, Iceland