Recall Z-0843-2024
FX Shoulder · initiated August 8, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Codes / lots: UDI-DI: 03701037309551, Lot: U0191
Reason for recall
Centered glenosphere box may contain an eccentric glenosphere.
FDA-determined 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.
Details
- Recall number
- Z-0843-2024
- Initiated
- August 8, 2023
- Posted by FDA
- January 29, 2024
- Product code
- PHX – Shoulder Prosthesis, Reverse Configuration
- Quantity
- 4
- Distribution
- US Nationwide distribution in the state of NJ.
- Recalling firm
- FX Shoulder, Dallas, TX