BEUDAMED
    FDA Recall Terminated

    SRS FAST SET PUTTY 3 CC BONE VOID FILLER-STERILE, Part Number SRS-005-FSP, Lot number N001101. Bone void filler.

    Recall: Z-0460-2012 · Initiated September 29, 2011

    Recall

    Recall Number
    Z-0460-2012
    Event Number
    60051
    Firm
    Synthes USA
    FEI Number
    3008812560
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    September 29, 2011
    Posted
    January 11, 2012
    Terminated
    December 18, 2014
    Address
    1230 Wilson Dr, West Chester, PA, 19380-4231

    Description

    SRS FAST SET PUTTY 3 CC BONE VOID FILLER-STERILE, Part Number SRS-005-FSP, Lot number N001101. Bone void filler.

    Reason

    A recent shipment carrying Norian SRS was lost by the carrier. Since the product was lost before final product release testing, Synthes is unable to confirm that Part Number SRS-005-FSP- Lot Number N001101 meets final product release requirements. The product contains all final labeling and cannot be visually distinguished from the product that has met final product release requirements.

    Action

    All Synthes accounts with a history of purchasing the product in the past two years will be notified by letter of the incident. All firm sales consultants will also receive written notification of the incident.

    Distribution

    Synthes USA sent a "NOTICE: MISSING SHIPMENT-NORIAN SRS" letter dated September 29, 2011 to all accounts with a history of purchasing the product in the past two years. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory to verify they have not received the affected product. Call 1-800-620-7025 ext. 5450 for questions concerning this notice.

    Quantity

    131 units