BEUDAMED
    FDA Recall Terminated

    Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture Reference Number: 222740

    Recall: Z-0446-06 · Initiated October 27, 2005

    Recall

    Recall Number
    Z-0446-06
    Event Number
    33990
    Firm
    Depuy Mitek, a Johnson & Johnson Co.
    FEI Number
    1221934
    Product Code
    MAI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 27, 2005
    Posted
    January 26, 2006
    Terminated
    May 2, 2006
    Address
    325 Paramount Dr, Raynham, MA, 02767-5199

    Description

    Depuy Mitek Fastin RC Anchor with Panacryl (2) strands Size 2 Panacryl Poly ***braided absorbable suture Reference Number: 222740

    Reason

    The device may contain one strand of suture instead of two strands

    Action

    DePuy Mitek initiated the recall to domestic accounts by letter on 10/27/05 and to J & J Affiliates by email.

    Distribution

    CA, IA, FL, MI, MO, OR, TX Foreign:Australia, Brazil, Sweden

    Quantity

    19 boxes (5 pieces each)