Device product
Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
Z-0361-2014
Product summary
- Firm
- Aesculap, Inc.
- Event
- Event 66534
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30
- Official record key
device-enforcement:Z-0361-2014
Official wording
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.
Code information: model no. ME020R
Distribution pattern: Worldwide distribution: USA (nationwide) GA, TN, CA, WY, NV, TX, OK, OH, and IL; and internationally to Canada.
Derived failure modes
-
Unknown
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.