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
Product summary
- 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
Mislabeled