Recall Z-2091-2016 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Smith & Nephew, Inc.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee r
| Date | May 26, 2016 |
| Status | Terminated |
| Reason | The surface inside of the femoral component, where cement is applied for adhesion, is below specification. |
| Root cause | Process control |
| Action | The firm sent an Urgent Product Recall letter dated May 26, 2016 to customers, via email and FedEx Overnight delivery . The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. Inspect inventory and locate any unused devices from the listed product and batch numbers, and quarantine them immediately. 2. Complete the Inventory Return Certification Form on the following page, indicating the quantities that need to be returned. If you do not have product to return, place an x in the column No Product to Return. Include your contact information |
| Quantity | 3 units |
| Distribution | Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081111 | LEGION HINGE KNEE SYSTEM Smith & Nephew, Inc., Jul 23, 2008 |