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Waldemar Link GmbH & Co. KG (Mfg Site) recalls SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented

Recalled March 20, 2024 · FDA recall Z-1296-2024 · 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
382 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, Hip Prosthesis Stem 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

Waldemar Link GmbH & Co. KG (Mfg Site) recalls SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented | RecallWatchUSA