Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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

FDA Recall Z-0361-2014 · Posted 2013-11-19

Recalling FirmAesculap, Inc.
Recall StatusTerminated
Product CodeLXH
Date Initiated2013-09-20
Date Terminated2014-12-16
Product Quantity30

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.

Firm Action

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

Root Cause

Device Design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑