FDAClass IINovember 27, 2013

Aesculap Arcadius XP L Trial Insertion Instrument recall

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

Why was Aesculap Arcadius XP L Trial Insertion Instrument recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

model no. ME020R

Product
Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
Recalling firm
Aesculap, Inc.
Quantity
30
Distribution
Worldwide distribution: USA (nationwide) GA, TN, CA, WY, NV, TX, OK, OH, and IL; and internationally to Canada.
Recall date
November 27, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls