FDA-Device2013-11-27Class II

Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)

Aesculap, Inc.
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.

Sold states
Worldwide distribution: USA (nationwide) GA, TN, CA, WY, NV, TX, OK, OH, and IL; and internationally to Canada.
Affected count
30
Manufactured in
3773 Corporate Pkwy, Center Valley, PA, United States
Products
Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0361-2014

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