Class II — Waldemar Link GmbH & Co. KG (Mfg Site)
| 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 | Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique |
| Product | Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75mm 16-2817/32 Tibial Component Modular, Small, W: 60mm 16-2817/35 Tibial Component Modular, Medium, W: 65mm 16-2817/37 Tibial Component Modular, Large, W: 75mm |
| Quantity | 114 units US; 2351 units OUS |
| Distribution | Nationwide Foreign: Algeria Argentina Australia Austria Belarus Belgium Brazil Bulgaria Canada China Colombia Czechia Denmark Ecuador Estonia Finland France Germany Greece Hungary India Indonesia Israel Italy Kenya Lithuania Luxembourg Mexico Netherlands Norway Peru Poland Romania Saudi Arabia Slovakia Slovenia Spain Sweden Switzerland Thailand Trkiye Ukraine United Arab Emirates United Kingdom … |
| Initiated | 2024-05-22 |
| Classified | 2024-07-18 |
| Recall number | Z-2411-2024 |
| 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 (Mfg Site) (Z-2411-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/94814/
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