Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0729-2019 — 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

U.S. FDA — Device Enforcement · Germany · 2018-12-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0729-2019
Date of alert
2018-12-04
Country / jurisdiction
Germany
Risk level
Class II
Risk type
recall
Brand
Waldemar Link GmbH & Co. KG (Mfg Site)
Product category
device
Product type
Devices
Reported risk: The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.