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 | Terminated |
| Reason | The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records. |
| Product | BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use. |
| Quantity | 31 |
| Distribution | US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA. |
| Initiated | 2018-12-04 |
| Classified | 2019-01-11 |
| Terminated | 2020-06-05 |
| Recall number | Z-0729-2019 |
| 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-0729-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81762/
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