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Recall Observatory FDA recall evidence

Device product

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

Z-2262-2015

June 24, 2015

Class II

Product summary

Firm
Encore Medical, Lp
Event
Event 71663
Status
Terminated
Classification
Class II
Quantity
10 units
Official record key
device-enforcement:Z-2262-2015

Official wording

Reason: 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.

Code information: Lot 53839799 and 414012

Distribution pattern: US Distribution to TX and GA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.