Recall Z-2967-2018 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Encore Medical, Lp
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.
| Date | May 14, 2018 |
| Status | Terminated |
| Reason | After receipt of a product complaint for the labeling, it was determined that this device does not have FDA clearance. |
| Root cause | No Marketing Application |
| Action | 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 extens |
| Quantity | 12 |
| Distribution | U.S. Distribution to states of: AZ, MO, MS, NY, OK, and UT; internationally to: Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.