Class II — Waldemar Link GmbH & Co. KG (Corp. Hq.)
| Recalling firm | WALDEMAR LINK GMBH & CO. KG |
|---|---|
| Registered facility | Waldemar Link GmbH & Co. KG (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Some lots of the LINK Universal Handle, with quick coupling, Stainless Steel, straight may suffer an immediate material failure intraoperatively when the instrument is used for the first time. The instrument can break in the middle. |
| Product | LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01 |
| Quantity | 32 devices |
| Distribution | US Nationwide distribution in the states of FL, KS, MI, NJ, VA. |
| Initiated | 2024-09-11 |
| Classified | 2024-09-24 |
| Recall number | Z-3245-2024 |
| 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 — Waldemar Link GmbH & Co. KG (Corp. Hq.) (Z-3245-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95344/
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