Recall Z-1902-2018 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Smith & Nephew, Inc.
smith&nephew 5o (5 degree) GENESIS(R) II VALGUS BUSHING, REF CATALOG NUMBER 71440014 The GENESIS II 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 replacement, or total kn
| Date | Apr 9, 2018 |
| Status | Terminated |
| Reason | A single lot of GENESIS II FEMORAL FIVE DEGREE VALGUS BUSHING due to a laser mark labeling error. The left valgus bushing was incorrectly laser marked as right and vice versa. |
| Root cause | Process control |
| Action | The firm sent an Urgent Medical Device Recall Notice dated April 9, 2018. 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 quantities of each batch that yo |
| Quantity | 18 units |
| Distribution | US Distribution to the states of : NC, IN, CO MI, PA, NY, MA, CA, GA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121393 | SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION Smith & Nephew, Inc., Aug 7, 2012 |