PlainRecalls
FDA Devices Moderate 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

Reported: March 6, 2024 Initiated: January 22, 2024 #Z-1219-2024

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

Details

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

Frequently Asked Questions

What product was recalled?
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. Recalled by Waldemar Link GmbH & Co. KG (Mfg Site).
Why was this product recalled?
Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
Which agency issued this recall?
This recall was issued by the FDA Devices on March 6, 2024. Severity: Moderate. Recall number: Z-1219-2024.