Z-0625-2024 Class II
FDA device recall Z-0625-2024 was initiated by Encore Medical, LP on Oct 5, 2023 and is designated Class II. Reason for recall: Mislabeling Affected quantity: 17 units.
Recall details
- Product Type
- Devices
- Report Date
- Jan 10, 2024
- Initiation Date
- Oct 5, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 units
Product description
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Reason for recall
Mislabeling
Distribution pattern
US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.
Code information
UDI: (01)00888912144612/Lot Number(s): 381P1167
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0625-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026