FDA-Device2013-06-19Class II
DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere.
DePuy Orthopaedics, Inc.
Hazard
The Glenosphere Orientation Guide Instrument Used with the Delta XTEND Reverse Shoulder is being recalled because an arrow that is etched on the instrument was incorrectly placed on the opposite side of the instrument. Using the improperly etched arrow as a guide could potentially lead to incorrect orientation of the glenosphere implant.
Sold states
Worldwide Distribution - USA Nationwide and countries of: Australia, Canada, Czech Republic, England, Germany, Switzerland and Turkey.
Affected count
20 units
Manufactured in
700 Orthopaedic Dr, N/A, Warsaw, IN, United States
Products
DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1520-2013Don't want to check this manually?
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