Device product
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.
Z-1023-2017
Product summary
- Firm
- Medacta Usa Inc
- Event
- Event 76034
- Status
- Terminated
- Classification
- Class II
- Quantity
- 82 units
- Official record key
device-enforcement:Z-1023-2017
Official wording
Reason: Damaged packaging, lack of sterility assurance
Code information: Lot #s 125212,144216, 148146
Distribution pattern: Worldwide Distribution- US (nationwide) distribution to states of: TX and CO; and countries of: Australia, Belgium, Spain, German, Italy and Switzerland.
Derived failure modes
-
Sterility assurance
lack of sterility