Class II
Medical Device Recall: SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented
Waldemar Link GmbH & Co. KG (Mfg Site) · February 6, 2024
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
0 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1299-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.