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Waldemar Link GmbH & Co. KG (Mfg Site) recalls BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mobility System is indicat
Recalled January 23, 2019 · FDA recall Z-0729-2019 · Waldemar Link GmbH & Co. KG (Mfg Site)
Hazard
The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records. · FDA Class II
Units
31
Sold at
US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA.
Description
The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to 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 intended for cemented and cementless use.
Manufacturer(s)
Waldemar Link GmbH & Co. KG (Mfg Site)
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →