Recall Z-0970-2015 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stelkast Co
EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.
| Date | Jan 14, 2015 (initiated Dec 1, 2014) |
| Status | Terminated |
| Reason | Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of this lead in may prevent or make assembly of the insert and tray difficult. |
| Root cause | Process design |
| Action | On December 1, 2014, phone calls were made to all direct accounts to notify them of the recall and to request immediate recovery and return of the SC3425 EXp PS Tibial Tray Inserts and SC3453 EXp CR-HF Inserts from their inventory. |
| Quantity | 553 |
| Distribution | TX, MD, IN, KS, CA, PA, GA, WA, NY, IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122883 | EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM Stelkast Company, Aug 5, 2013 |