Recall Z-0200-2019 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Smith & Nephew, Inc.
Smith+Nephew Orthopaedic Division LEGION A/P FEMORAL CUTTING BLOCK, SIZE 6 REF 71434411, QTY: (1) The LEGION AP Femoral Cutting Block is a reusable surgical instrument used to make bone cuts on the distal femur to prepare the bone to receive a LEGION femoral implant.
| Date | Sep 18, 2018 |
| Status | Terminated |
| Reason | One lot of the Legion AP femoral cutting block, size 6, was manufactured with an oversized spring. |
| Root cause | Process control |
| Action | The firm, Smith & Nephew, notified their consignees with a notice entitled " Urgent Medical Device Recall Notice" by email on 09/18/2018. The notice The notice explained the problem and the potential hazard and requested return of the recalled units. The consignees are instructed to do the following: Please inspect your inventory and locate any 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 ca |
| Quantity | 6 units |
| Distribution | US Distribution to the states of: KS and TN. |
| 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 |