Smith & Nephew, Inc., Endoscopy Div. recalls Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 Intended Use: For art…

Recall date

September 10, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0156-2016

FDA classification

Class II

Brand / firm

Smith & Nephew, Inc., Endoscopy Div.

Sold / distributed

Worldwide Distribution - US Nationwide, Canada, Austria, Australia, Belgium, China, Spain, Finland, France, Great Britain, Greece, Germany, Hungary, India, Italy, Japan, Korea, Lithuania, Latvia, Netherlands, Poland, Portugal, Sweden, Thailand, Turkey, Ukraine and Venezuela

Why it was recalled

Sterility of device is compromised due to breach in the packaging

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Smith & Nephew MOSAICPLASTY DP- Disposable Harvesting System 4.5 mm, Sterile Part Number: 7209235 Intended Use: For arthroscopic (knee and ankle) and open osteochondral grafting fix for osteochondral (cartilage) defects.