BEUDAMED
    FDA Recall Terminated

    ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Research Circle, Alachua, FL 32615 USA.

    Recall: Z-0939-2014 · Initiated December 6, 2013

    Recall

    Recall Number
    Z-0939-2014
    Event Number
    67246
    Firm
    RTI Surgical, Inc.
    FEI Number
    3002719998
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 6, 2013
    Posted
    February 7, 2014
    Terminated
    September 15, 2014
    Address
    11621 Research Cir, Alachua, FL, 32615-6825

    Description

    ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Research Circle, Alachua, FL 32615 USA.

    Reason

    RTI Surgical, Inc. of Alachua, FL is recalling their OPTEFORM Allograft Paste, 5cc as it may contain a 10 cc fluid dispenser. The 10cc fluid dispenser does not include the correct fluid fill line reference for reconstitution of 5cc past allografts.

    Action

    RTI Surgical issued a: URGENT: Medical Device Recall Notification dated December 6, 2013 to their customer. The customer was instructed to quarantine the product immediately and return to RTI Surgical, Inc. for final disposition. For questions or concerns, call 386-418-8888.

    Distribution

    Distributed to Florida.

    Quantity

    14 units