BEUDAMED
    FDA Recall Open, Classified

    Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H

    Recall: Z-0319-2025 · Initiated September 25, 2024

    Recall

    Recall Number
    Z-0319-2025
    Event Number
    95516
    Firm
    Ethicon, Inc.
    FEI Number
    3017102971
    Product Code
    GAM
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 25, 2024
    Posted
    November 7, 2024
    Address
    1000 Route 202, Raritan, NJ, 08869-1425

    Description

    Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H

    Reason

    Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.

    Action

    An URGENT: FIELD SAFETY NOTICE was sent to customers beginning on 9/25/24. ACTION REQUIRED 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). If you have product subject to this recall, please maintain a copy of this notice with the quarantined product and keep a copy for your records. 2. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 3. Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and fax or email to [Enter Affiliate Information] within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 4. Customers are required to return unused VICRYL" (polyglactin 910) Suture subject to this recall that are in inventory immediately. To receive credit or replacement product as appropriate, customers must return product subject to this recall no later than December 31, 2024 to [Enter Affiliate Information]. Any non-affected product and any product returned after the date specified will not be eligible for credit or replacement product. 5. Keep this notice visibly posted for awareness until all product subject to this recall has been returned to [Enter Affiliate Information]. If you require any assistance with

    Distribution

    International distribution to the country of China.

    Quantity

    31,032 units