ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525

Recall Insight

This FDA Devices action (record #Z-1419-2022) was formally reported on July 27, 2022, with the manufacturer initiating the action on June 29, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. DePuy Orthopaedics, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records indicate 872 units units are affected.

The documented reason for this recall is: Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical … Distribution data in the federal record shows the product reached: Nationwide Foreign: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, K…. 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 4 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.