Z-0843-2024 Class II Ongoing
FDA device recall Z-0843-2024 was initiated by FX SHOULDER on August 8, 2023 and is designated Class II. Reason for recall: Centered glenosphere box may contain an eccentric glenosphere. The recall status is ongoing. Affected quantity: 4.
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2024
- Initiation Date
- August 8, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4
Product Description
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Reason for Recall
Centered glenosphere box may contain an eccentric glenosphere.
Distribution Pattern
US Nationwide distribution in the state of NJ.
Code Information
UDI-DI: 03701037309551, Lot: U0191