BEUDAMED
    FDA Recall Terminated

    Agee-WristJack Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.

    Recall: Z-0136-2017 · Initiated September 14, 2016

    Recall

    Recall Number
    Z-0136-2017
    Event Number
    75255
    Firm
    Hand Biomechanics Lab Inc
    FEI Number
    2919128
    Product Code
    JEC
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    September 14, 2016
    Terminated
    November 15, 2016
    Address
    77 Scripps Dr, Ste 104, Sacramento, CA, 95825-6209

    Description

    Agee-WristJack Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.

    Reason

    A number of Agee WristJack Fracture Reduction Systems have been manufactured with a molded beam slightly larger than optimal. This may result in the surgeon experiencing difficulty fine-tuning the length (red) and radial/ulnar alignment (blue) adjustments on the device.

    Action

    Hand Biomechanics Lab, Inc. sent a Voluntary Medical Device Recall letter to all affected customers beginning on September 14, 2016 and sent by phone/fax numbers - or e-mail. Letters request return of devices which have not yet been used. Customers with questions were instructed to contact Customer Service at (800) 522-5778. For questions regarding this recall call 916-923-5073.

    Distribution

    Nationwide Distribution

    Quantity

    65 units