BEUDAMED
    FDA Recall Terminated

    Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones.

    Recall: Z-2127-2014 · Initiated May 19, 2014

    Recall

    Recall Number
    Z-2127-2014
    Event Number
    68445
    Firm
    Small Bone Innovations
    FEI Number
    3003640913
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 19, 2014
    Posted
    July 30, 2014
    Terminated
    October 8, 2014
    Address
    1380 S Pennsylvania Ave, Morrisville, PA, 19067

    Description

    Small Bone Innovations 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments Indications for Use: AutoFIX" cannu lated screws are indicated for the treatment of fractures, non-unions, pseudoarthrosis and degenerative changes as well as corrective osteotom ies geared towards a functionally stable osteosynthesis in small bones.

    Reason

    Small Bone Innovations (SBi) is recalling all lots of 3.0/4.0mm AutoFIX" Cannulated Compression Screw System Sets, Implants, and Instruments to update the IFU.

    Action

    Small Bone Innovations sent an Urgent Medical Device Recall letter, dated May 19, 2014, to all affected customers. The letter that described the product problem, and the action to be taken by the customer. was sent to sales reps, stocking customers, and distributors. Customers were instructed that a copy of the IFU should be stored with each unpackaged AutoFIX 3.0/4.0mm Compression Screw Sets, Implants, or Instruments in their current inventory. Customers were instructed to return all packaged affected product which would be replaced by the firm with an updated IFU. A Federal Express return label was included to facilitate the return shipment. Customers were instructed to complete, sign, and return with the product the Return Material Authorization (RMA) document. For questions regarding this recall call 215-428-1791.

    Distribution

    Nationwide Distribution including TN, OK, AZ, PA, TX, MO, NY, NC, CA, FL, WA, AL, IN, NH, SD, and OH.

    Quantity

    506