Recall Z-2883-2018
Smith & Nephew, Inc. · initiated August 1, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
Codes / lots: Lot Numbers: 16CMB0061A, 16CMB0066A
Reason for recall
Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.
FDA-determined cause: Employee error
Action taken
The firm notified its consignees of the problem and the recall by email on 08/01/2018. The firm requested the return of the product.
Details
- Recall number
- Z-2883-2018
- Initiated
- August 1, 2017
- Terminated
- February 19, 2019
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Quantity
- 27 units
- Distribution
- Australia, Austria, Germany, Great Britain, Poland, Spain
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN