Recall Z-2262-2015— Encore Medical, Lp
Class II · Terminated
Class II FDA medical device recall by Encore Medical, Lp, initiated 2015-06-24, terminated 2016-06-24. FDA's recall record names no specific 510(k) clearance for this event. Product: FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139. 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..
- Recalling firm
- Encore Medical, Lp
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-24
- Terminated
- 2016-06-24
- Firm location
- Austin, TX, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.