Class II — Dufner Instrumente GmbH
| Recalling firm | DUFNER INSTRUMENTE GMBH |
|---|---|
| Registered facility | DUFNER INSTRUMENTE GMBH (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Tungsten carbide plate, which is intended to hold the sewing needle securely, can break when holding the sewing needle under pressure and result in in patient tissue injury |
| Product | DUFNER Instrumente GmbH-De Bakey Slim Needleholder- intended to hold a suturing needle for closing wounds during suturing and surgical procedures Reference Number: 18044-23 |
| Quantity | 30 units |
| Distribution | IL |
| Initiated | 2020-06-03 |
| Classified | 2020-07-07 |
| Terminated | 2021-01-21 |
| Recall number | Z-2534-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Dufner Instrumente GmbH (Z-2534-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85894/
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