FDAFDA · Food and drugs·Recall number Z-1219-2024
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
Published March 6, 2024 · Recall initiated: January 22, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Distributor
- Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the countries of Germany, Switzerland.
- Lot
- UDI-DI: 04026575230747 Lot Numbers: 2334253, 2325426
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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