FDA Enforcement
Class II
Ongoing
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
Recall: Z-1219-2024
·
Reported March 6, 2024
Enforcement
- Recall Number
- Z-1219-2024
- Event ID
- 93944
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- March 6, 2024
- Initiation Date
- January 22, 2024
- Classification Date
- February 29, 2024
- Address
- Oststr. 4-10, Norderstedt, N/A, Germany
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
Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
Code Info
UDI-DI: 04026575230747 Lot Numbers: 2334253, 2325426
Distribution
Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the countries of Germany, Switzerland.