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Class 2 Device Recall Aesculap Arcadius Trial Insertion Instrument (ME020R/ME020RUS) |
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Date Initiated by Firm |
September 20, 2013 |
Date Posted |
November 19, 2013 |
Recall Status1 |
Terminated 3 on December 16, 2014 |
Recall Number |
Z-0361-2014 |
Recall Event ID |
66534 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
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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 PA 18034-8217
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For Additional Information Contact |
Customer Support 800-258-1946 Ext. 5067
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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.
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FDA Determined Cause 2 |
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
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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