Waldemar Link GmbH & Co. KG (Mfg Site): The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.

Agency Publication Date: January 11, 2019

Affected Products

Product: 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.

Lot# 1707121

Lot Numbers:

1707121

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.

Lot# 1707116

Lot Numbers:

1707116

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81762

Status: Resolved

Manufacturer: Waldemar Link GmbH & Co. KG (Mfg Site)

Manufactured In: Germany

Units Affected: 2 products (30; 31)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

Lot# 1707121

Lot Numbers:

1707121

Lot# 1707116

Lot Numbers:

1707116