device · product 1 of 1
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 number
- Z-0001-2013
- Initiated
- June 18, 2012
- Classification
- Class II
- Status
- Terminated
- Recalling firm
- Synthes USA HQ, Inc.
- Quantity
- 1602
App-derived interpretation
Unknown
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.
Official device-enrichment evidence · Sourced
Labeling design
Inspect official wording and provenance
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.
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.