Device product
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Z-0625-2024
Product summary
- Event
- Event 93623
- Status
- Completed
- Classification
- Class II
- Quantity
- 17 units
- Official record key
device-enforcement:Z-0625-2024
Official wording
Reason: Mislabeling
Code information: UDI: (01)00888912144612/Lot Number(s): 381P1167
Distribution pattern: US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.
Derived failure modes
-
Labeling or packaging
Mislabeling