Z-1023-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 25, 2017
- Initiation Date
- December 7, 2016
- Termination Date
- November 15, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 82 units
Product Description
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.
Reason for Recall
Damaged packaging, lack of sterility assurance
Distribution Pattern
Worldwide Distribution- US (nationwide) distribution to states of: TX and CO; and countries of: Australia, Belgium, Spain, German, Italy and Switzerland.
Code Information
Lot #s 125212,144216, 148146