rHead, Radial Implant 6 mm Collar, Size 4. Orthopedic implant for replacement of the proximal end of the radius in the Stryker rHead Radial Head and Uni-Elbow system.

Recall Insight

This FDA Devices action (record #Z-2732-2018) was formally reported on August 15, 2018, with the manufacturer initiating the action on October 24, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Howmedica Osteonics Corp. is listed as the recalling firm, operating out of Mahwah, NJ. Federal records indicate 286 units are affected.

The documented reason for this recall is: Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery. Distribution data in the federal record shows the product reached: Distribution US Nationwide.. 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, NHTSA and USDA FSIS 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 8 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.