REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral an

Recall Insight

This FDA Devices action (record #Z-1203-2014) was formally reported on March 19, 2014, with the manufacturer initiating the action on February 24, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. DePuy Orthopaedics, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records indicate 129 units are affected.

The documented reason for this recall is: DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM¿ Noiles Rotating Hinge Femur with Pin devices. The outer carton and sh… Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysi…. 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 12 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.