BEUDAMED
    FDA Recall Terminated

    Porcine Anorganic Bone Mineral 4.0cc

    Recall: Z-0752-2019 · Initiated October 30, 2018

    Recall

    Recall Number
    Z-0752-2019
    Event Number
    81626
    Firm
    Collagen Matrix Inc
    FEI Number
    3008817245
    Product Code
    NPM
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 30, 2018
    Terminated
    May 12, 2020
    Address
    15 Thornton Rd, Oakland, NJ, 07436-3115

    Description

    Porcine Anorganic Bone Mineral 4.0cc

    Reason

    There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled.

    Action

    On October 30, 2018 Collagen Matrix, notified their 2 distributors of the issue via email. The two distributors provided notices to their customers. Customers were advised to take the following actions: 1. If any of the items noted in the scope of the letter is held in stock, please return them along with a copy of the letter to the address provided. Replacement product will be provided upon receipt of the return. 2. Complete the Certificate of Acknowledgement within 15 days of receipt and email the completed form to the email address noted within your letter.

    Distribution

    FL, TX

    Quantity

    136 units