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U.S. Department of Health and Human Services

Class 2 Device Recall Aesculap Arcadius Trial Insertion Instrument (ME020R/ME020RUS)

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 Class 2 Recall
Aesculap Arcadius Trial Insertion Instrument (ME020R/ME020RUS)
see related information
Date Posted November 19, 2013
Recall Status1 Open
Recall Number Z-0361-2014
Recall Event ID 66534
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
Code Information model no. ME020R
Recalling Firm/
Manufacturer
Aesculap, Inc.
3773 Corporate Pkwy
Center Valley, Pennsylvania 18034-8217
For Additional Information Contact Customer Support
800-258-1946 Ext. 5067
Manufacturer Reason
for Recall
The trial insertion instrument may disassemble during use due to a potentially weak weld on then trial inserter shaft block area located near the thumb wheel.
FDA Determined
Cause 2
DESIGN: Device Design
Action An Important Product Removal Notification dated September 20, 2013 was sent to customers.
Quantity in Commerce 30
Distribution Worldwide distribution: USA (nationwide) GA, TN, CA, WY, NV, TX, OK, OH, and IL; and internationally to Canada.
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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