Recall Z-0042-04 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Ortho Development Corporation
Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System.
| Date | Oct 15, 2003 (initiated Sep 15, 2003) |
| Status | Terminated |
| Reason | The guide pin which rotationally constrains the tibial punch within the punch guide, may fall out. |
| Root cause | Other |
| Action | The firm has telephoned all distributors regarding the recall. An advisory note and product return request letters were sent to all distributors on 9/15/03. |
| Quantity | 27 |
| Distribution | Units were sent to distributors in AZ, CA, FL, MO, OK and TX. Units were also distributed to firm's parent company in Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.