FDA-Device2024-03-20Class II
SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented
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.
Sold states
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.
Affected count
34 units
Manufactured in
Oststr. 4-10, N/A, Norderstedt, N/A, Germany
Products
SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1297-2024More Waldemar Link GmbH & Co. KG (Mfg Site) recalls
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