FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
Reported: August 5, 2015 Initiated: June 24, 2015 #Z-2262-2015
Product Description
FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
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.
Details
- Recalling Firm
- Encore Medical, Lp
- Units Affected
- 10 units
- Distribution
- US Distribution to TX and GA.
- Location
- Austin, TX
Frequently Asked Questions
What product was recalled? ▼
FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139. Recalled by Encore Medical, Lp. Units affected: 10 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 5, 2015. Severity: Moderate. Recall number: Z-2262-2015.
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