Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.

Recall Insight

This FDA Devices action (record #Z-1798-2015) was formally reported on June 24, 2015, with the manufacturer initiating the action on April 22, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Biomet, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records indicate 27 units are affected.

The documented reason for this recall is: The Left and Right orientation of the trial was incorrectly etched on one side. When the instrument is rotated about the axis of the handle 180 degrees to view the other side, the etch on the handle now shows R on the … Distribution data in the federal record shows the product reached: Worldwide Distribution -- US, including the state of IL, NJ, Canada, Netherlands, and Chile.. 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 11 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.