Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.

Recall Insight

This FDA Devices action (record #Z-1127-2020) was formally reported on February 19, 2020, with the manufacturer initiating the action on December 16, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Nextremity Solutions is listed as the recalling firm, operating out of Warsaw, IN. Federal records indicate 40 units are affected.

The documented reason for this recall is: The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate. Distribution data in the federal record shows the product reached: Domestic distribution to AL, CA, FL, GA, ID, IL, IA, KY, LA, ME, MA, MI, MN, MS, NE, NJ, NY, OH ,OK, OR, TX, and WA.. 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 6 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.