CORE¿ Trumpet Handpiece only — Class II medical device recall Z-0135-2017
Terminated recall by ConMed Corporation, reported 2016-10-26, distributed nationwide. The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromi
| Recall number | Z-0135-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConMed Corporation, Utica, NY, United States |
| Recall initiated | 2016-06-27 |
| Classified | 2016-10-18 |
| Reported by FDA | 2016-10-26 |
| Terminated | 2018-06-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CZ, DE, DK, GB, GT, IE, IT, UY |
| Reason classes | sterility, packaging |
| Lot numbers | 110609X, 20160308X |
| Model numbers | CD8450 |
Product
CORE¿ Trumpet Handpiece only, Catalog Number CD8450 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
Reason for recall
The packaging seal may contain a crease. The crease may result in an open channel. These channels may compromise sterility of the product.
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-0135-2017. 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.