Synthes USA HQ, Inc.: Medical Device Recall in 2012 - (Recall #: Z-0001-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class II

Date Initiated: June 18, 2012

Date Posted: October 10, 2012

Recall Number: Z-0001-2013

Event ID: 62773

Reason for Recall:

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 associated with this system. The labeling reflects updated technique recommendations and emphasizes the importance of avoiding rod mis-alignment.

Status: Terminated

Product Quantity: 1602

Code Information:

Minimally Invasive Redution Screw System (MIRS) - Labeling number J11031-A

Distribution Pattern:

Nationwide Distribution including CA, FL, ID, IN, MD, MI, MT, LA, NY, OH, PA, TX, VA and WA.

Voluntary or Mandated:

Voluntary: Firm initiated