Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210

Recall Insight

This FDA Devices action (record #Z-0843-2024) was formally reported on February 7, 2024, with the manufacturer initiating the action on August 8, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Fx Shoulder is listed as the recalling firm, operating out of Dallas, TX. Federal records indicate 4 units are affected.

The documented reason for this recall is: Centered glenosphere box may contain an eccentric glenosphere. Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of NJ.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.