Medical device recalls Moderate risk

Smith & Nephew, Inc. recalls RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY: (1)

Recall date
March 30, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1916-2017
FDA classification
Class II
Brand / firm
Smith & Nephew, Inc.
Sold / distributed
Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United…

Why it was recalled

The stability data does not support the product labeled with a 10-year shelf life.

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

What was recalled

RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY: (1)

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