Recall Z-1105-2018 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Smith & Nephew, Inc.
smith&nephew, LEGION HK FEMORAL WEDGE (WEDGE AND SCREW), 5 MM, SIZE 5, REF 71422159, QTY: (1), STERILE The Revision Knee System Components are indicated for rheumatoid arthritis; post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight, and activity levels are compatible with an adequate long-term result; failed osteotomies, unicompartmental replace
| Date | Feb 1, 2018 |
| Status | Terminated |
| Reason | The screws package with devices within lot 14AAP6352A were 5 MM instead of 10MM and are too short to be used with the Legion HK Distal Wedge Size 5. |
| Root cause | Process control |
| Action | The firm initiated their recall by email on February 1, 2018. The letter stated the following: "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 have no product to return, please put an X in the appropriate location below. 3. If you have product to return, please list the batch numbers and quantit |
| Quantity | 28 units |
| Distribution | Worldwide Distribution - US Distribution to the states of: NY, IL, NJ, TX, CO, and to the countries of : Belgium, Great Britain, Australia, Germany, Netherlands, Norway. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081111 | LEGION HINGE KNEE SYSTEM Smith & Nephew, Inc., Jul 23, 2008 |