FDAFDA · Food and drugs·Recall number Z-1520-2013
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.
Published June 19, 2013 · Recall initiated: May 3, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- DePuy Orthopaedics, Inc.
- Distributor
- Worldwide Distribution - USA Nationwide and countries of: Australia, Canada, Czech Republic, England, Germany, Switzerland and Turkey.
- Lot
- Part Number 230795000/Lot Number 5120443
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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