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U.S. Department of Health and Human Services

Class 2 Device Recall Glenosphere Orientation Guide for the Delta XTEND Reverse Shoulder System

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 Class 2 Recall
Glenosphere Orientation Guide for the Delta XTEND Reverse Shoulder System
see related information
Date Posted June 07, 2013
Recall Status1 Terminated on August 28, 2013
Recall Number Z-1520-2013
Recall Event ID 65081
Product Classification Template - Product Code HWT
Product 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.
Code Information Part Number 230795000/Lot Number 5120443
Recalling Firm/
Manufacturer
DePuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw, Indiana 46582-3994
For Additional Information Contact Mindy Tinsley
574-372-7136
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action DePuy Synthes sent and Urgent Information - Medical Device Instrument Recall Notice letter dated May 3, 2013 via email to affected customers. The letter identified the affected product, problem, clinical implications, and potential adverse events. Arrangements will be made for all affected Glenosphere Orientation Guides (part #230795000/lot #5120443) to be returned. Customers were asked to return the response form via fax (574-371-4964). Product related questions should be directed to DePuy Synthes Joint Reconstruction (1-888-554-2482). Recall inquiries should be directed to Kim Earle, Recall Coordinator, 574-371-4917 (M-F; 8a.m.-5 p.m. EDT).
Quantity in Commerce 20 units
Distribution Worldwide Distribution - USA Nationwide and countries of: Australia, Canada, Czech Republic, England, Germany, Switzerland and Turkey.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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