Z-0361-2014Class II

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

Name: Z-0361-2014 Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
Creator: Aesculap, Inc.
Published: 2013-09-20
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2013-09-20 / Terminated / root cause: design

FDA source

Aesculap, Inc. began a recall of Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US) on 2013-09-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0361-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-20
Posted: 2013-11-19
Terminated: 2014-12-16
Recalling firm: Aesculap Inc
Product: Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: model no. ME020R

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0361-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0361-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-19

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)