Recall Z-0361-2014— Aesculap, Inc.
Class II · Terminated
Class II FDA medical device recall by Aesculap, Inc., initiated 2013-09-20, terminated 2014-12-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US). 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..
- Recalling firm
- Aesculap, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-09-20
- Terminated
- 2014-12-16
- Firm location
- Center Valley, PA, United States
Product description
Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.