BEUDAMED
    FDA Recall Terminated

    Coated VICRYL RAPIDETM (Polyglactin 910) Suture

    Recall: Z-0693-2018 · Initiated August 17, 2017

    Recall

    Recall Number
    Z-0693-2018
    Event Number
    79086
    Firm
    Ethicon, Inc. Us
    FEI Number
    2210968
    Product Code
    GAM
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    August 17, 2017
    Terminated
    May 8, 2019
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    Coated VICRYL RAPIDETM (Polyglactin 910) Suture

    Reason

    On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 910) Suture that were distributed to the field. During finished goods testing, a suture damage was identified on a lot of VICRYL RAPIDETM Suture. During the course of the subsequent investigation, the suture also failed knot tensile strength testing.

    Action

    On August 31, 2017 a Medical Device recall letter (Reference 2210968-08.31.17-003-R) was issued requesting customers to do the following: 1. Examine your inventory immediately to determine if you have product subject to this recall (removal) on hand and quarantine such product(s). 2. Remove the product subject to this recall (removal) and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. 3. If any product subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return. If you have additional questions regarding this recall (removal) or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266). As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail or by fax: " Online: www.fda.gov/medwatch/report.htm " Regular Mail: Use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm Mail to: MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787 " Fax: 1-800-FDA-0178

    Distribution

    Nationally

    Quantity

    129,372 Eaches (Internationally)