Reported Jun 19, 2013 · Terminated
DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse…
DePuy Orthopaedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- DePuy Glenosphere
- orientation guide Product UsageThe glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The orientation guide is used to properly align the glenosphere
- Lot codes and dates
- Part Number 230795000/Lot Number 5120443
- Amount recalled
- 20 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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