Recall Z-1819-2009 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew Inc
LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants.
| Date | Aug 23, 2009 (initiated Jan 22, 2009) |
| Status | Terminated |
| Reason | Products were mispackaged. |
| Root cause | Process control |
| Action | All affected Smith & Nephew Sales Representatives were notified of the problem and the recall via email and overnight mail on January 22, 2009. All affected Smith & Nephew International Distributors were notified via email and telephone on January 22, 2009. They were instructed to immediately quarantine the product for return. |
| Quantity | 16 units |
| Distribution | Worldwide Distribution -- US, Canada, Australia, Germany, GB, Italy, Switzerland, Spain, and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043440 | SMITH & NEPHEW, INC. REVISION KNEE SYSTEM Smith & Nephew, Inc., Feb 18, 2005 |