BEUDAMED
    FDA Recall Terminated

    GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures

    Recall: Z-1619-2013 · Initiated March 6, 2013

    Recall

    Recall Number
    Z-1619-2013
    Event Number
    65166
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    MAI
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    March 6, 2013
    Posted
    July 1, 2013
    Terminated
    July 22, 2013
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures

    Reason

    Incorrect blue/white suture was used.

    Action

    ConMed Linvatec sent an "URGENT: Medical Device Recall Notification" letter by FedEx next day delivery on March 6, 2013, to notify all direct consignees of the recall. If the account no longer had the product in possess, they were asked to respond via a reply form or to contact ConMed Linvatec Customer Service to obtain a Service Request number for return and credit of unused unopened product. All returned product for this action would be identified, segregated and quarantined per the firm's procedures. Any returned product not part of the recall will be dispositioned in accordance with the firm's procedures. Please accept our sincere apology for any inconvenience this action may have caused . Should you have any questions please contact our Customer Service department at (800) 237-0169.

    Distribution

    US Distribution including the states of FL, KY, LA, MI, NC, and NY.

    Quantity

    60 each of both units