[Recalled] 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 — Mislabeled: Pa
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| 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 |
|---|---|
| Brand / manufacturer | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1219-2024 |
| Country of notice | Germany |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 22 January 2024 |
| EAN / barcode | 04026575230747 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
This Class II recall concerns device products distributed in Germany and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Waldemar Link GmbH & Co. KG (Mfg Site)
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.