Smith & Nephew, Inc. recalls Tibial knee prosthesis

Recalled August 19, 2020 · FDA recall Z-2774-2020 · Smith & Nephew

Hazard

Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects. · FDA Class II

Units

1,845 units

Sold at

Domestic Distribution: AL, LA ,MN, KY, AR, MN, GA, TX, WI, NJ, NC, CT, NY, OH, IA, IN, NC, MA, SC, NV, CT, WV, NY, OH, MN, MI, SC, TN, FL, AZ, PA and MO. International Distribution: Austria, Belgium, China, Canada, Switzerland, Colombia, Cyprus, Check Republic, Denmark, Spain, France, Great Britain, Greece, Hungary, India, Italy, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Russia, Sweden, Slovenia, Turkey and Ukraine.

Description

Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.

Product

Tibial knee prosthesis

Manufacturer(s)

Smith & Nephew, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →