Smith & Nephew, Inc., Endoscopy Div. recalls Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instru…
- Recall date
- April 4, 2013
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0699-2016
- FDA classification
- Class II
- Brand / firm
- Smith & Nephew, Inc., Endoscopy Div.
- Sold / distributed
- 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 So…
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument
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