BiMobile UHMWPE Liner: ID-28mm/OD-54mm recalled over labeling errors

Recall date

December 4, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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 indicated…

Recall number

Z-0729-2019

FDA classification

Class II

Brand / firm

Waldemar Link GmbH & Co. KG (Mfg Site)

Sold / distributed

US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.