Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
FDA device recall Z-0843-2024 · posted 2024-01-29 · Open, Classified
Recall details
- Recalling firm
- FX SHOULDER
- Reason for recall
- Centered glenosphere box may contain an eccentric glenosphere.
- 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.
- Root cause
- Labeling mix-ups
- Status
- Open, Classified
- Product code
- PHX
- Quantity affected
- 4
- Distribution
- US Nationwide distribution in the state of NJ.
- Date initiated
- 2023-08-08
- Date posted
- 2024-01-29
- Location
- Dallas, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Humelock TiN Coated Glenosphere (K191146) | Fx Shoulder USA, Inc. | 2020-07-15 |