BEUDAMED
    FDA Recall Terminated

    3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.

    Recall: Z-0034-2009 · Initiated September 9, 2008

    Recall

    Recall Number
    Z-0034-2009
    Event Number
    49494
    Firm
    Surgical Specialties Corp
    FEI Number
    2522801
    Product Code
    GAR
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    September 9, 2008
    Posted
    October 2, 2008
    Terminated
    March 27, 2009
    Address
    100 Dennis Dr, Reading, PA, 19606

    Description

    3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.

    Reason

    mislabeled product - labeled as 3-0 black mono nylon contains 4-0 black braided silk suture

    Action

    The recalling firm issued a Recall letter dated 9/9/08 to its customers. The letter informed the customers of the problem, the need to conduct a sub-recall, and return the product. Contact Surgical Specialties Corp. at 1-610-404-1000 for assistance.

    Distribution

    USA--AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MD, MI, MS, NC, NJ, NY, OH, TN, TX, VA, and WA. OUS: Australia, Canada, and Fiji Islands.

    Quantity

    956 boxes