FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139

FDA device recall Z-2262-2015 · posted 2015-07-27 · Terminated

Recall details

Recalling firm

Encore Medical, Lp

Reason for recall

The markings on the distal face of the instruments are mis-oriented by 180. This includes Anterior and Posterior, which the surgeon uses to correctly place the cut block on the resectioned face of the femur. The cut block is not symmetric, so correct orientation of the instrument in the A/P direction is critical to making proper anterior, posterior, and chamfer cuts to fit the femoral implant.

Action taken

DJO Surgical sent an " Urgent Field Safety Notice" dated June 30, 2015, to the affected customer. The recalling firm requested the customer return the affected product for a replacement. For further questions, please call (512) 834-6302.

Root cause

Component design/selection

Status

Terminated

Product code

HWT

Quantity affected

10 units

Distribution

US Distribution to TX and GA.

Date initiated

2015-06-24

Date posted

2015-07-27

Date terminated

2016-06-24

Location

Austin, TX