BEUDAMED
    FDA Recall Terminated

    Coated VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed. Intended use: Soft Tissue approximation.

    Recall: Z-1608-2010 · Initiated April 20, 2010

    Recall

    Recall Number
    Z-1608-2010
    Event Number
    55428
    Firm
    Ethicon, Inc. US
    FEI Number
    2210968
    Product Code
    GAM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 20, 2010
    Posted
    May 18, 2010
    Terminated
    July 19, 2011
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    Coated VICRYL RAPIDE (polyglactin 910) Braided Coated Synthetic Absorbable Suture, Undyed. Intended use: Soft Tissue approximation.

    Reason

    Channels in the packaging seal that can lead to suture degradation and loss of packaging integrity. Recall Z-0021-2009 was initiated in 2008. Ethicon had decided to recall all sutures product during the may to June 2007 timeframe.

    Action

    "Expansion of 2008 Voluntary Recall" notification letters dated April 20, 2010 were sent by second day UPS to customers, distributors, Materials Managers, Director of Surgical Services, and Directors of Risk Management. The letters state that the expansion includes 37 lots of products. The letters describe the product, problem and action t to be taken by customers. The customers were instructed to immediately discontinue use of any of the affected product and to remove from all inventory and returned to Stericycle. If they are not returning product, they should mail the enclosed business reply card to Stericycle. The customers should notify their end customers of this recall. If their end customers have the affected product they should first call 1-888-345-0483 to get appropriate shipping labels. THIS RECALL EXPANSION ONLY IMPACTS THE VICRYL RAPID SUTURE. THIS DOES NOT INCLUDE THE VICRYL* ADN VICRYL* PLUS PRODUCTS. Please don't hesitate to contact Christie Bielinski directly at 908-218-2553 or via email at [email protected] should you have any questions or require additional information.

    Distribution

    Worldwide distribution: USA and Austria, Belgium, Canada, Chile, China, Czech Republic, Egypt, Germany, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Korea, Malaysia, Middle East, Netherlands Antilles, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom

    Quantity

    118332 eaches were sent to the US Distribution Center, of which 69936 eaches were shipped to primary consignees.