Recall Z-2538-2019 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Smith & Nephew, Inc.
LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e., medial collateral and/or lateral collateral ligament) are absent or incompetent.
| Date | Jan 15, 2018 |
| Status | Completed |
| Reason | The affected products were inadvertently packaged with an incorrect screw component. |
| Root cause | Process control |
| Action | The firm sent an Urgent Medical Device Recall Notice letter dated January 15, 2018 to consignees via email. The letter identified the affected product, problem and actions to be taken. Consignees are asked to inspect inventory, locate and quarantine affected, unused devices. Affected product will be returned to Smith & Nephew. All consignees are asked to complete the Response Form, even if they do not have product to return. For questions or concerns regarding this recall contact FieldActions@smith-nephew.com. |
| Quantity | 12 units |
| Distribution | Foreign countries of; France, Germany, Netherlands, Norway, Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043440 | SMITH & NEPHEW, INC. REVISION KNEE SYSTEM Smith & Nephew, Inc., Feb 18, 2005 |