FDAClass IIJune 19, 2013

DePuy Glenosphere orientation guide Product Usage: The recall

DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The…

Why was DePuy Glenosphere orientation guide Product Usage: The 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part Number 230795000/Lot Number 5120443

Product
DePuy Glenosphere orientation guide Product Usage: The glenosphere orientation guide is an instrument used in reverse shoulder arthroplasty. The…
Recalling firm
DePuy Orthopaedics, Inc.
Quantity
20 units
Distribution
Worldwide Distribution - USA Nationwide and countries of: Australia, Canada, Czech Republic, England, Germany, Switzerland and Turkey.
Recall date
June 19, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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