FDA Enforcement
Class II
Completed
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Recall: Z-0625-2024
·
Reported January 10, 2024
Enforcement
- Recall Number
- Z-0625-2024
- Event ID
- 93623
- Classification
- Class II
- Status
- Completed
- Product Type
- Devices
- Firm
- Encore Medical, LP
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 10, 2024
- Initiation Date
- October 5, 2023
- Classification Date
- January 2, 2024
- Address
- 9800 Metric Blvd, N/A, Austin, TX, 78758-5445, United States
Description
Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Reason
Mislabeling
Code Info
UDI: (01)00888912144612/Lot Number(s): 381P1167
Distribution
US Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA, AL, FL, CA.
Quantity
17 units