BEUDAMED
    FDA Recall Terminated

    Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N

    Recall: Z-2042-2016 · Initiated May 20, 2016

    Recall

    Recall Number
    Z-2042-2016
    Event Number
    74230
    Firm
    SSC- Surgical Specialties Corporation
    FEI Number
    3011767135
    Product Code
    GAW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 20, 2016
    Terminated
    August 12, 2016
    Address
    9993 Marconi Dr, San Diego, CA, 92154-7271

    Description

    Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N

    Reason

    Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture.

    Action

    A customer notification letter dated 5/20/16 was sent to all customers to inform them that Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture. Customers are instructed to complete the attached customer acknowledgement form and return via fax to Surgical Specialties' Quality Assurance department at (610) 404-4010 or return via email to [email protected]. Customers with any questions are instructed to contact Kelly Knappenberger at (484) 220-2402 or Kris Liberacki at (262) 994-8083.

    Distribution

    TX, ME, MA, MI, OH, KS, MN, KS, TN, GA

    Quantity

    36 boxes (432 units)