Recall Z-0965-2012 ยท ISY Joint, Knee, External Limb Component
Ossur H / F
Total Knee Junior Model Number 1100 Product Usage: The Total Knee Junior is an external polycentric prosthetic knee with a geometric locking system.
| Date | Feb 6, 2012 (initiated Aug 10, 2009) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Nonconforming Material/Component |
| Action | 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 ad |
| Quantity | 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: Australia, Canada, China, France, Germany, Hong Kong, Israel, Japan, Malaysia, Netherlands, New Zealand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.