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Recall Observatory FDA recall evidence

Device product

LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right

Z-2048-2023

March 18, 2021

Class II

Product summary

Firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Event
Event 92500
Status
Ongoing
Classification
Class II
Quantity
16 units
Official record key
device-enforcement:Z-2048-2023

Official wording

Reason: The firm discovered through customer complaints that device segments may not meet specifications.

Code information: Item No. 15-2979/01; UDI-DI: 04026575328093.

Distribution pattern: Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    may not meet specifications