MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).

Recall Insight

This FDA Devices action (record #Z-0001-2013) was formally reported on October 10, 2012, with the manufacturer initiating the action on June 18, 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 1602.

The documented reason for this recall is: Synthes is initiating a Medical Device Labeling Correction following a detailed review of the current labeling in response to reported complaints. Synthes has identified technique measures and has updated the labeling … Distribution data in the federal record shows the product reached: Nationwide Distribution including CA, FL, ID, IN, MD, MI, MT, LA, NY, OH, PA, TX, VA and WA.. 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.