Waldemar Link GmbH & Co. KG (Mfg Site) Recall 93944
Description: 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
Waldemar Link GmbH & Co. KG (Mfg Site) Recall 93944 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1219-2024 |
| Event ID | 93944 |
| Event Description | 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 |
| Product Type | Devices |
| Distribution | Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the countries of Germany, Switzerland. |
| Recall Reason | Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery |
| Device Classification | 20240306 |
| Device Code Info | UDI-DI: 04026575230747 Lot Numbers: 2334253, 2325426 |
| Center Classification Date | 20240229 |
| Recall Initiation Date | 20240122 |
| Recalling Firm | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Initial Notification | |
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