FDAFDA · Food and drugs·Recall number Z-1023-2017
Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480mm, Type Straight, Mat Co-Cr-Mo The rods act as a connector between the different pedicle screws to create a stable construct for the stabilization and fusion of the lumbar and thoracic spine. Indications for Use: The M.U.S.T. pedicle screw system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). The pedicle screws are connected by 5.5mm Titanium alloy or CoCrMo rods to create a stable construct. The construct is secured using a set screw made of CoCrMo.
Published January 25, 2017 · Recall initiated: December 7, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Damaged packaging, lack of sterility assurance
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Medacta Usa Inc
- Distributor
- Worldwide Distribution- US (nationwide) distribution to states of: TX and CO; and countries of: Australia, Belgium, Spain, German, Italy and Switzerland.
- Lot
- Lot #s 125212,144216, 148146
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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