Recall Z-0911-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Scorpio X3 UHMPWE Tibial Inserts and Scorpio X3 UHMWPE Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ. Intended to be used with cemented or cementless components in primary or revision total knee arthroplasty.
| Date | Mar 2, 2010 (initiated Feb 17, 2006) |
| Status | Terminated |
| Reason | Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts. |
| Root cause | Process design |
| Action | Stryker Orthopaedics issued an "Important Market Withdrawal" notification dated February 17, 2007 via federal express. Consignees were informed of the affected product and asked to retrieve, reconcile and return product via Return Material Authorization to the firm. For further information, contact Stryker Orthopaedics Quality Assurance at 1-201-831-5825. |
| Quantity | 594 units total - all products. |
| Distribution | Worldwide Distribution -- United States and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051977 | SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS Howmedica Osteonics Corp., Oct 12, 2005 |