BEUDAMED
    FDA Recall Terminated

    Panacryl Synthetic Absorbable Suture. Poly(L-lactide/glycolide) Suture. Undyed (white), braided, this suture is a synthetic absorbable sterile surgical suture composed of a copolymer of 95% lactide and 5% glycolide. The suture is coated with a copolymer composed of 90% caprolactone and 10% glycolide.

    Recall: Z-0907-06 · Initiated February 16, 2006

    Recall

    Recall Number
    Z-0907-06
    Event Number
    34682
    Firm
    Ethicon, Inc. US
    FEI Number
    2210968
    Product Code
    GAM
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 16, 2006
    Posted
    May 27, 2006
    Terminated
    December 7, 2006
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    Panacryl Synthetic Absorbable Suture. Poly(L-lactide/glycolide) Suture. Undyed (white), braided, this suture is a synthetic absorbable sterile surgical suture composed of a copolymer of 95% lactide and 5% glycolide. The suture is coated with a copolymer composed of 90% caprolactone and 10% glycolide.

    Reason

    The unique absorption profile of Panacryl in the suture could act as a foreign body so that surgeons should consider its use in specific situations.

    Action

    Customer notification letter was sent out on 3/28/2006 alerting the customer to the problem with the suture.

    Distribution

    There were 2202 customers in the US and 10 international customers. This product is no longer being marketed by Ethicon. Its last shipment was 7/1/2002. There are US Military and VA Hospitals included. All International customers are the J&J Medical Products Distribution Ctrs located in Australia, Canada, Hong Kong, Indonesia, Japan, Korea, Malaysia, Philippines, Taiwan, and Thailand.

    Quantity

    1,061,712 sutures