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 | Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery |
| Product | LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 184-280/12 |
| Distribution | Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the countries of Germany, Switzerland. |
| Initiated | 2024-01-22 |
| Classified | 2024-02-29 |
| Recall number | Z-1219-2024 |
| 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-1219-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93944/
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