Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap, Part Number 04.631.502 Non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation.

Recall Insight

This FDA Devices action (record #Z-0396-2014) was formally reported on December 4, 2013, with the manufacturer initiating the action on September 7, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Synthes USA Hq, Inc. is listed as the recalling firm, operating out of West Chester, PA. Federal records list the affected scope as 745.

The documented reason for this recall is: This action is being initiated following a detailed investigation in response to reported complaints of post-operative locking cap loosening. Synthes has concluded that if the construct is mis-aligned during final tigh… Distribution data in the federal record shows the product reached: Nationwide Distribution including CA, CO, CT, FL, GA, ID, IL, IN, LA, MA, MD, MI, MN, MT, NC, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.