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BiMobile UHMWPE Liner: ID-28mm/OD-54mm, Reference Number 184-260/04 The LINK BiMobile Dual Mob...

FDA Recall #Z-0729-2019 — Class II — December 4, 2018

Recall #Z-0729-2019 Date: December 4, 2018 Classification: Class II Status: Terminated

Product Description

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.

Reason for Recall

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

Recalling Firm

Waldemar Link GmbH & Co. KG (Mfg Site) — Norderstedt

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

31

Distribution

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

Code Information

Lot# 1707116

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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