FDAFDA · Food and drugs·Recall number Z-0625-2024
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Published January 10, 2024 · Recall initiated: October 5, 2023
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Mislabeling
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Encore Medical, LP
- Distributor
- US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.
- Lot
- UDI: (01)00888912144612/Lot Number(s): 381P1167
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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