Recall Z-0843-2024 ยท PHX Shoulder Prosthesis, Reverse Configuration
FX SHOULDER
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
| Date | Jan 29, 2024 (initiated Aug 8, 2023) |
| Status | Open, Classified |
| Reason | Centered glenosphere box may contain an eccentric glenosphere. |
| Root cause | Labeling mix-ups |
| Action | 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. |
| Quantity | 4 |
| Distribution | US Nationwide distribution in the state of NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191146 | Humelock TiN Coated Glenosphere Fx Shoulder USA, Inc., Jul 15, 2020 |