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Terminated

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

FDA Recall Z-2262-2015 · Posted 2015-07-27

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeHWT
Date Initiated2015-06-24
Date Terminated2016-06-24
Product Quantity10 units

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.

Firm Action

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

Distribution Pattern

US Distribution to TX and GA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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