TriMed Hex Driver 1.2, 55mm AO Cannulated, REF HXDRIVR-1.2C AO, nonsterile, Rx. The firm name on the label is TriMed Inc., Santa Clarita, CA.

Recall Insight

This FDA Devices action (record #Z-0357-2020) was formally reported on November 20, 2019, with the manufacturer initiating the action on September 28, 2018. It is classified under Moderate severity (Class II), with a current status of Ongoing. TriMed Inc. is listed as the recalling firm, operating out of Santa Clarita, CA. Federal records indicate 467 hex drivers units are affected.

The documented reason for this recall is: The epoxy on Apex manufactured epoxy-coated instruments can pop off. Distribution data in the federal record shows the product reached: Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.. 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 7 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.