Data Foundry

Medical device recalls 2024

LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head — Class II medical device recall Z-1219-2024

Ongoing recall by Waldemar Link GmbH & Co. KG (Mfg Site), reported 2024-03-06, distributed nationwide. Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G

Recall numberZ-1219-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmWaldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, Germany
Recall initiated2024-01-22
Classified2024-02-29
Reported by FDA2024-03-06
DistributedNationwide (US)
Countries outside the USCH, DE
Reason classeslabeling
UPC / GTIN / UDI-DI04026575230747
Lot numbers2325426, 2334253
Model numbers184-280/12

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

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1219-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.