Z-1575-2014 Class II Terminated
FDA device recall Z-1575-2014 was initiated by Blue Belt Technologies MN on April 11, 2014 and is designated Class II. Reason for recall: Blue Belt Technologies is conducting a voluntary recall for their Navio PFS system which is used during orthopedic knee surgery. One of the electronic modules inside the computer cart assembly may hav… The recall status is terminated (terminated June 10, 2014). Affected quantity: 11.
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2014
- Initiation Date
- April 11, 2014
- Termination Date
- June 10, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11
Product Description
NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS-02010, NPFS 02020.
Reason for Recall
Blue Belt Technologies is conducting a voluntary recall for their Navio PFS system which is used during orthopedic knee surgery. One of the electronic modules inside the computer cart assembly may have a defect in one of its components that could result in a latent failure.
Distribution Pattern
USA: CA, PA, OH, TX. OUS: BELGIUM, SCOTLAND, UNITED KINGDOM.
Code Information
SN000090, SN000091, SN000092, SN000187, SN000200, SN000204, SN000226, SN000231, SN000232, SN000246, SN000247