Home / Recalls / Blue Belt Technologies MN / Z-1575-2014

Z-1575-2014 Class II Terminated

Recalled by Blue Belt Technologies MN — Plymouth, MN

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

Other recalls by Blue Belt Technologies MN

  • Z-1943-2014 Class II — Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicond (June 4, 2014)
  • Z-1942-2014 Class II — Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicond (June 4, 2014)
  • Z-1995-2013 Class II — Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO (July 19, 2013)