FDA-Device2017-05-10Class II

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

Smith & Nephew, Inc.
Hazard

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

Sold states
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 Arab Emirates, and Venezuela
Affected count
2017 units
Manufactured in
1450 E Brooks Rd, Memphis, TN, United States
Products
RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QTY: (1)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1916-2017

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