FDA-Device2016-02-10Class II
Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument
Smith & Nephew, Inc., Endoscopy Div.
Hazard
Driver does not meet specification, oversized. Driver may not be able to be fully inserted into the screw, or screw may become stuck on the driver.
Sold states
Worldwide Distribution - US Distribution to the states of : AK, AL, CA, CO, FL, IL, IN, MI, NE, NJ, NY, OH, OK, PA, SC, TN and TX., and to the countries of : Austria, Australia, Canada, Dubai, Great Britain, India, Italy, Korea, Malaysia, Netherlands, Portugal, Sweden, Switzerland, Singapore and South Africa.
Affected count
157
Manufactured in
130 Forbes Blvd, N/A, Mansfield, MA, United States
Products
Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0699-2016Don't want to check this manually?
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