FDAFDA · Food and drugs·Recall number Z-0361-2014
Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
Published November 27, 2013 · Recall initiated: September 20, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aesculap, Inc.
- Distributor
- Worldwide distribution: USA (nationwide) GA, TN, CA, WY, NV, TX, OK, OH, and IL; and internationally to Canada.
- Lot
- model no. ME020R
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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