BEUDAMED
    FDA Recall Terminated

    Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp.

    Recall: Z-0060-2017 · Initiated August 18, 2016

    Recall

    Recall Number
    Z-0060-2017
    Event Number
    75077
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    HWA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 18, 2016
    Posted
    October 7, 2016
    Terminated
    August 1, 2018
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2006

    Description

    Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., Mahwah, NJ, USA, A Subsidiary of Stryker Corp.

    Reason

    Stryker Orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the Trident Universal Impactor/Positioner.

    Action

    Stryker sent an Urgent Medical Device Recall Notification dated August 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions Needed: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2. Branches/Agencies: Return all affected products available at your location to Stryker C/0 Stericycle 3. Hospitals/Branches: Complete and sign the enclosed Business Reply Form and fax a copy to 877-546-0444 or email to Stericycle [email protected]. Our records indicate that you have received the above referenced instrument. It is our responsibility to ensure that customers who may have received this affected instrument also receive this important communication. Please assist us in meeting our regulatory obligation by faxing back the attached Business Reply Form within 5 days. We regret any inconvenience this action may cause you and if you have any questions, feel free to contact me at (201) 831-6693. For further questions regarding this recall, please call (201) 831-5000.

    Distribution

    US and Internationally

    Quantity

    3,768 units