Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
FDA device recall Z-0361-2014 · posted 2013-11-19 · Terminated
Recall details
- Recalling firm
- Aesculap, Inc.
- 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.
- Action taken
- An Important Product Removal Notification dated September 20, 2013 was sent to customers.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 30
- Distribution
- Worldwide distribution: USA (nationwide) GA, TN, CA, WY, NV, TX, OK, OH, and IL; and internationally to Canada.
- Date initiated
- 2013-09-20
- Date posted
- 2013-11-19
- Date terminated
- 2014-12-16
- Location
- Center Valley, PA
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