Z-2883-2018 Class II Terminated
FDA device recall Z-2883-2018 was initiated by Smith & Nephew, Inc. on August 1, 2017 and is designated Class II. 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. The recall status is terminated (terminated February 19, 2019). Affected quantity: 27 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 29, 2018
- Initiation Date
- August 1, 2017
- Termination Date
- February 19, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 27 units
Product Description
GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
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.
Distribution Pattern
Australia, Austria, Germany, Great Britain, Poland, Spain
Code Information
Lot Numbers: 16CMB0061A, 16CMB0066A