FDA-Device2019-01-23Class II
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 intended for cemented and cementless use.
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.
Sold states
US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA.
Affected count
30
Manufactured in
Oststr. 4-10, Norderstedt, Germany
Products
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 intended for cemented and cementless use.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0728-2019Don't want to check this manually?
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