BEUDAMED
    FDA Recall Terminated

    GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

    Recall: Z-0880-2017 · Initiated November 9, 2016

    Recall

    Recall Number
    Z-0880-2017
    Event Number
    75792
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    NDE
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    November 9, 2016
    Terminated
    March 27, 2019
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006

    Description

    GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker Trauma GmbH, Prof.-Kuntscher-Strasse 1-5, Schonkirchen, Germany 24232; T2 K-Wire, Sterile R Intended for the temporary stabilization of bone segments or fragments

    Reason

    A review of packaging revealed the seal integrity of the pouch may be compromised. More specifically, there is a potential that the sterile pouch is not sealed at one end due to a manufacturing error.

    Action

    Stryker sent an Urgent Medical Device Removal letter dated November 9, 2016, to all affected customers via UPS (with return receipt). Stericycle will be handling the returns. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inform users of the Medical Device Recall and forward the notice to all those individuals who need to be aware within their organization. Return all affected products available at their location to: Stryker C/O Stericycle 2670 Executive Dr., Suite A Indianapolis, IN 46241 Attn: RA 2016-169 - Event XXX Customers were also instructed to complete and sign the enclosed Business Reply Form and return to Stericycle. Customers with questions should call +1-201-851-6683. For questions regarding this recall call 201-831-5000.

    Distribution

    Worldwide Distribution - US (nationwide) Internationally to AU, CA, CL, CH, ES, FR, GB, SE, JP, FR, ZA, and NL.

    Quantity

    2,084 units