BEUDAMED
    FDA Enforcement Class II Ongoing

    NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

    Recall: Z-1263-2024 · Reported March 13, 2024

    Enforcement

    Recall Number
    Z-1263-2024
    Event ID
    94026
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 13, 2024
    Initiation Date
    February 6, 2024
    Classification Date
    March 6, 2024
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006, United States

    Description

    NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM

    Reason

    Potential packaging breaches of inner blister and outer sterile blister.

    Code Info

    Part No. 5537-G-311-E; GTIN: 07613327288063; Lot No. EP81Y7, YL5VKA; Expiration Date: 10/07/2028.

    Distribution

    Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.

    Quantity

    39 units (US); 10 units (OUS)