Medical device recalls Moderate risk

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

Get recall alerts

Free email alert whenever Smith & Nephew, Inc., Endoscopy Div. has a new recall — straight from official government data. Unsubscribe anytime.

More recalls from: Smith & Nephew, Inc., Endoscopy Div.