FDA recall Z-2883-2018

Smith & Nephew, Inc. · Class II · device

Product

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

Australia, Austria, Germany, Great Britain, Poland, Spain

Key facts

Status
Terminated
Initiation date
2017-08-01
Report date
2018-08-29
Termination date
2019-02-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2883-2018