Recall Z-0361-2014 ยท LXH Orthopedic Manual Surgical Instrument
Aesculap, Inc.
Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
| Date | Nov 19, 2013 (initiated Sep 20, 2013) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.