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Recall Observatory FDA recall evidence

Device 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

Z-1219-2024

January 22, 2024

Class II

Product summary

Firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Event
Event 93944
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1219-2024

Official wording

Reason: Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery

Code information: UDI-DI: 04026575230747 Lot Numbers: 2334253, 2325426

Distribution pattern: Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the countries of Germany, Switzerland.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Mislabeled