FDA Device recall Z-0843-2024
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
- FDA Device
- Class II
- ongoing
- Published 2024-02-07
On 2024-02-07 the FDA classified a Class II recall of Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210 by Fx Shoulder, citing centered glenosphere box may contain an eccentric glenosphere.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0843-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-08-08 |
| Published | 2024-02-07 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fx Shoulder |
| Distribution | US |
Product
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Reason
Centered glenosphere box may contain an eccentric glenosphere.
Identifiers
| code_info | UDI-DI: 03701037309551, Lot: U0191 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0843-2024%22
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