RecallDepth

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

Company
Aesculap Inc
Recall Initiated
September 20, 2013
Posted
November 19, 2013
Terminated
December 16, 2014
Recall Number
Z-0361-2014
Quantity
30
Firm Location
Center Valley, PA

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.

Distribution

Worldwide distribution: USA (nationwide) GA, TN, CA, WY, NV, TX, OK, OH, and IL; and internationally to Canada.

Lot / Code Info

model no. ME020R

Root Cause

Device Design

Action Taken

An Important Product Removal Notification dated September 20, 2013 was sent to customers.

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