FDA-Device2024-03-20Class II
SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
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.
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
0 units
Manufactured in
Oststr. 4-10, N/A, Norderstedt, N/A, Germany
Products
SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1299-2024Don't want to check this manually?
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