FX Shoulder Glenosphere (FX Shoulder) – Component Mismatch (2023)
This recall may present a risk under certain conditions.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Brand
FX SHOULDER
Lot Codes / Batch Numbers
UDI-DI: 03701037309551, Lot: U0191
Products Sold
UDI-DI: 03701037309551, Lot: U0191
FX SHOULDER is recalling Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210 due to Centered glenosphere box may contain an eccentric glenosphere.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Centered glenosphere box may contain an eccentric glenosphere.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026