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Aesculap, Inc. recalls Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
Recalled November 27, 2013 · FDA recall Z-0361-2014 · Aesculap
Hazard
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 Class II
Units
30
Sold at
Worldwide distribution: USA (nationwide) GA, TN, CA, WY, NV, TX, OK, OH, and IL; and internationally to Canada.
Description
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.
Product
Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
Manufacturer(s)
Aesculap, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →