Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
This recall is currently active, issued January 29, 2024. It was issued by Fx Shoulder.
- Company
- Fx Shoulder
- Recall Initiated
- August 8, 2023
- Posted
- January 29, 2024
- Recall Number
- Z-0843-2024
- Quantity
- 4
- Firm Location
- Dallas, TX
- Official Source
- View on FDA website ↗
Reason for Recall
Centered glenosphere box may contain an eccentric glenosphere.
Distribution
US Nationwide distribution in the state of NJ.
Lot / Code Info
UDI-DI: 03701037309551, Lot: U0191
Root Cause
Labeling mix-ups
Action Taken
On 8/8/23, the firm telephoned the customer and informed them of the recall. The customer was asked to quarantine the device, which was subsequently collected by the firm.