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FDA-Device2012-10-10Class IIMISBRANDING

Synthes MIRS for MATRIX Spine System recalled for labeling correction on rod alignment technique

Synthes
OTHERNationwide distribution

Check Synthes MIRS spine system labeling

Synthes has updated labeling for its MIRS (Minimally Invasive Reduction Screw) spine fixation system used in back surgery. The update provides corrected technique recommendations and emphasizes proper rod alignment during installation. No injuries have been reported.

  • Review the updated labeling for your MIRS system to understand the corrected technique recommendations
  • Pay special attention to guidance on avoiding rod mis-alignment during placement
  • Contact Synthes if you have questions about the updated instructions
Hazard

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.

Sold states
Nationwide Distribution including CA, FL, ID, IN, MD, MI, MT, LA, NY, OH, PA, TX, VA and WA.
Affected count
1602
Manufactured in
1302 Wrights Ln E, N/A, West Chester, PA, United States
Products
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).

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0001-2013

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