Aesculap Arcadius XP L Trial Insertion Instrument — Class II medical device recall Z-0361-2014
Terminated recall by Aesculap, Inc., reported 2013-11-27, distributed nationwide. The trial insertion instrument may disassemble during use due to a potentially weak weld on then trial inserte
| Recall number | Z-0361-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aesculap, Inc., Center Valley, PA, United States |
| Recall initiated | 2013-09-20 |
| Classified | 2013-11-19 |
| Reported by FDA | 2013-11-27 |
| Terminated | 2014-12-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 30 |
| Model numbers | ME020R |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0361-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.