The Recall Desk

FDA (Devices) recall action 81762

Waldemar Link GmbH & Co. KG (Mfg Site) recalled 2 products on 2019-01-23

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-01-23
Critical
0
Units
61

Why these products were recalled

The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2019-01-23

    Waldemar Link Recalls BiMobile UHMWPE Liners Due to Labeling Errors

    Waldemar Link is recalling 31 BiMobile UHMWPE Liners because internal labels may contain incorrect part numbers, risking errors in patient records.

    Product
    BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intend
    Category
    Distribution
    8 states
  • ModerateFDA (Devices)··2019-01-23

    Waldemar Link BiMobile UHMWPE Liner Recalled for Incorrect Internal Labeling

    Waldemar Link is recalling 30 BiMobile UHMWPE Liners because internal labeling may contain incorrect part numbers, risking errors in patient records.

    Product
    BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02 The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intend
    Category
    Distribution
    8 states