TiN Coated Glenosphere recallZ-0843-2024 · Fx Shoulder · initiated Aug 8, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fx Shoulder or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Centered glenosphere box may contain an eccentric glenosphere.
FDA root cause category: Labeling mix-ups
What the company is doing
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.
Recall details
- Recall number
- Z-0843-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 8, 2023
- Posted by the FDA
- Jan 29, 2024
- Recalling firm
- Fx Shoulder
- Quantity
- 4
- Product code
- PHX
- FDA submissions
- K191146
- Distribution
- US Nationwide distribution in the state of NJ.
Product description
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Code information (models, lots, serial numbers)
UDI-DI: 03701037309551, Lot: U0191
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- TiN Coated Glenosphere 115-3210Fx Solutions · Shoulder Prosthesis, Reverse Configuration1 recall4 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under K191146 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- TiN Coated Glenosphere 115-3610Fx Solutions · Shoulder Prosthesis, Reverse Configuration17 reports
- TiN Coated Glenosphere 115-3613Fx Solutions · Shoulder Prosthesis, Reverse Configuration3 reports
- TiN Coated Glenosphere 115-4010Fx Solutions · Shoulder Prosthesis, Reverse Configuration2 reports
- TiN Coated Glenosphere 115-3211Fx Solutions · Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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