FDA-Device2017-05-10Class II
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, 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
1416 units
Manufactured in
1450 E Brooks Rd, Memphis, TN, United States
Products
RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1910-2017Don't want to check this manually?
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