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Waldemar Link GmbH & Co. KG (Mfg Site) recalls SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
Recalled March 20, 2024 · FDA recall Z-1298-2024 · Waldemar Link GmbH & Co. KG (Mfg Site)
Hazard
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery. · FDA Class II
Units
153 Units
Sold at
US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, NJ, NV, PA, TN, TX, VA, WA.
Description
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
Product
SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
Manufacturer(s)
Waldemar Link GmbH & Co. KG (Mfg Site)
Made in
Germany
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →