Z-1219-2024 Class II Ongoing
FDA device recall Z-1219-2024 was initiated by Waldemar Link GmbH & Co. KG (Mfg Site) on Jan 22, 2024 and is designated Class II. Reason for recall: Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 6, 2024
- Initiation Date
- Jan 22, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
Product 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
Reason for Recall
Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
Distribution Pattern
Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the countries of Germany, Switzerland.
Code Information
UDI-DI: 04026575230747 Lot Numbers: 2334253, 2325426
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1219-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026