FDA Medical Device Recalls (openFDA)
Aesculap, Inc.: Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
- Recall number
- Z-0361-2014
- Recalling firm
- Aesculap, Inc.
- Product
- Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
- Status
- Terminated
- Initiated
- 2013-09-20
- Posted
- 2013-11-19
- Terminated
- 2014-12-16
- Reason
- 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
- Device Design
- Action
- An Important Product Removal Notification dated September 20, 2013 was sent to customers.
- Quantity
- 30
- Distribution
- Worldwide distribution: USA (nationwide) GA, TN, CA, WY, NV, TX, OK, OH, and IL; and internationally to Canada.
- Lot, serial or model codes
- model no. ME020R
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28