Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174

Recall Insight

This FDA Devices action (record #Z-1039-2026) was formally reported on January 21, 2026, with the manufacturer initiating the action on October 29, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medicrea International is listed as the recalling firm, operating out of Rillieux La Pape. Federal records indicate 44 units units are affected.

The documented reason for this recall is: Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant. Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of TN, CA, MN, NC, TX, FL, OH, RI, VA.. 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. Because this recall is recent, remedy windows and replacement inventory are most likely still actively available from the firm or retailer. Always cross-check the recall number against the official agency page before relying on any summary.