Reported Oct 10, 2012 · Terminated
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the…
Synthes USA HQ, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes USA HQ, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- 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).
- Lot codes and dates
- Minimally Invasive Redution Screw System (MIRS) - Labeling number J11031-A
- Amount recalled
- 1602
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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