FDA-Device2023-07-05Class II

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

Waldemar Link GmbH & Co. KG (Mfg Site)
Hazard

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

Sold states
Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.
Affected count
13 units
Manufactured in
Oststr. 4-10, N/A, Norderstedt, N/A, Germany
Products
LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2049-2023

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