Foundation Knee System NON Sterile Femoral A/p Cut recall
FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
Why was Foundation Knee System NON Sterile Femoral A/p Cut 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 53839799 and 414012
- Product
- FOUNDATION KNEE SYSTEM NON STERILE Femoral A/P Cut Block - Type II REF 800-01-139
- Recalling firm
- Encore Medical, Lp
- Quantity
- 10 units
- Distribution
- US Distribution to TX and GA.
- Recall date
- August 5, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)