ORTHOFIX, Connector System, SMALL SET SCREW, REF 79-2003

Recall Insight

This FDA Devices action (record #Z-1363-2018) was formally reported on April 18, 2018, with the manufacturer initiating the action on February 23, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Orthofix, Inc is listed as the recalling firm, operating out of Lewisville, TX. Federal records indicate 397 units units are affected.

The documented reason for this recall is: Orthofix is conducting a voluntary recall of the Connector System Large Set Screw (PN: 79-2002) with affected Lot Numbers 001 and 002, and Small Set Screw (PN: 79-2003) with affected Lot Numbers 002, 003 and 004. Throug… Distribution data in the federal record shows the product reached: US. 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.