Recall Z-1249-2015 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Microport Orthopedics INC.
EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component.
| Date | Mar 6, 2015 (initiated Feb 2, 2015) |
| Status | Terminated |
| Reason | Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product. |
| Root cause | Device Design |
| Action | MicroPort Orthopedics sent an Urgent Action Required letter dated January 29, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their stock including all consignment stock to determine if they have any affected product. If they have affected product they should return immediately to the MicroPort Orthopedics Inc. Distribution Center at 11481 Gulf Stream, Arlington, TN 38002. Mark all return shipping boxes with "RECALL" for identification and processing. Customers with questions |
| Quantity | 17 units |
| Distribution | Worldwide Distribution - USA including AL, AZ, ID, KS, KS, MO, TX, IA, WV and Internationally to Canada and The Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093552 | EVOLUTION MP TOTAL KNEE SYSTEM Wrightmedicaltechnologyinc, Mar 4, 2010 |