FDA Device

Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.

Hazard

The labeling is missing the size/diameter information.

What You Should Do

Remedy

DJO Surgical sent an Urgent Field Safety Notice dated September 16, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter requested the consignees complete and return a response card and return affected devices for replacement. For further questions call (512) 832-6302.

Products

Exprt Precision System: Revision Knee, Model Number 160-010-726/738 For use with the Exprt Knee System in total knee arthroplasty to replace the native patella.
UPC
471T1-001/011; 472T1-000/014; 473T1-000/015; 474T1-000/010; 475T1-000/008

Units Affected

209 units