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 reaming guide and the guide rod can't be screwed into the intended depth. The reason for this is a reduced depth of the core hole in the stem. A reaming guide that is not screwed in completely may lead to a proximal preparation in the depth that is not sufficient and to a neck that can't be positioned correctly. The correct fit of the neck can't be verified by means of the guide rod. |
| Product | LINK STEM with Microporous Surface MP Reconstruction Prosthesis, CEMENTLESS (Size XS-0, D: 12mm, L: 160mm), Reference Number 172-916/12 Product Usage: The LINK® STEM with Microporous Surface MP® Reconstruction Prosthesis, CEMENTLESS System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The LINK® STEM with Microporous Surface MP® Reconstruction Prosthesis, CEMENTLESS System is indicated for the following conditions: Revision arthroplasty due to juxta-articular bone defects Revision of … |
| Quantity | 11 |
| Distribution | US Nationwide in the states of: FL, GA, IA, IN, KS, MI, MN, and TN. |
| Initiated | 2018-12-07 |
| Classified | 2019-01-14 |
| Terminated | 2019-12-17 |
| Recall number | Z-0733-2019 |
| 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-0733-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81778/
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