Foundation Modular Femoral Stem, Part Number, 220-10-110. Knee prosthesis component. The Foundation Revision Knee is a total knee system indicated as knee joint replacement for patients suffering from pain and dysfunction.

After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance.

The firm, DJO, sent an "URGENT FIELD SAFETY NOTICE" letter dated 5/14/2018 to it's customers via email, on May 14, 2018 and contained the following information: Description of Issue, Quantity in Field, product information and code, Action required, and an Acknowledgement form with contact information. The customers were instructed to: check your inventory for part number 220-10-110; Customer Service has already requested that these be quarantined by your agency; Contact Customer Service to request an RMA for return of these devices. As there are no currently cleared 10x100 femoral stem extensions, there is no product available for replacement; and complete the attached acknowledgment form, even if you do not have the affected product, and email the form to [email protected] by May 18, 2018. Modular Femoral Cemented Stem -- 220-10-110 -determined that this device does not have FDA clearance. If you have any questions, please contact Manager, Regulatory Affairs at (512) 834-6255 or by email at [email protected].