Recall Z-0092-2018 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew, Inc.
smith&nephew LEGION L-WEDGE, 10 MM DIS X 5 MM POS, SIZE 4, SCREW-ON FEMORAL WEDGE, REF 71421733, STERILE R Product The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis; osteoarthritis; degenerative arthritis; and failed osteotomies, hemiarthroplasties; unicompartmental replacement; or total knee arthroplasties. The components are designed for use in
| Date | Sep 14, 2017 |
| Status | Terminated |
| Reason | The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw. |
| Root cause | Mixed-up of materials/components |
| Action | Smith & Nephew sent an Urgent Medical Device Recall Notice letter dated September 14, 2017 to consignees via email. The letter identified the affected product, problem and actions to be taken. The consignees (distributors) were directed as follows: Required Actions: 1. Please inspect your inventory and locate any unused devices from the listed product and batch numbers on the first page of this Field Action Notification, and quarantine them immediately. a. If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. 2. If you hav |
| Quantity | 10 units |
| Distribution | US, Belgium, Ecuador, Netherlands, Puerto Rico, Switzerland, Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041106 | REVISION KNEE SYSTEM Smith & Nephew, Inc., Jul 1, 2004 |