BEUDAMED
    FDA Recall Terminated

    Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.

    Recall: Z-2744-2015 · Initiated August 5, 2015

    Recall

    Recall Number
    Z-2744-2015
    Event Number
    71940
    Firm
    Biomet Spine, LLC
    FEI Number
    3012447612
    Product Code
    KWQ
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    August 5, 2015
    Posted
    September 9, 2015
    Terminated
    February 10, 2016
    Address
    310 Interlocken Pkwy, Ste 120, Broomfield, CO, 80021-3464

    Description

    Biomet Parsippany, NJ. 4 0 MM X 14 MM Variable Screw C-Tek Maxan Anterior Cervical Plate System. Lot 375440.

    Reason

    Some of P/N 14-521614B Lot 375440 was mislabeled as P/N 14-521614 Lot 375440.

    Action

    Zimmer Biomet sent an Urgent Medical Device Recall Notice dated August 5, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by customer. Customers were instructed to immediately locate and discontinue use of the affected product. This action requires the immediate location and discontinued use of the item and its immediate return to Zimmer Biomet Spine. Specifically, customers were REQUIRED to take the following steps: " Immediately locate and remove from circulation the items consigned/loaned to your account as identified on page two of this notice. " Carefully follow the instructions on the enclosed "Response Form". " If you have further distributed these items to medical facilities, you MUST notify them of this action. This letter MUST be given to the person responsible for receiving recall notices. However, you are charged with the location and return of these items. Health care professionals and consumers may report serious adverse events or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone: Online: Fax: Phone: Regular Mail: www. fda .gov /MedWatch/report.htm (800) FDA-0178 (800} FDA-1088 Use postage-paid FDA form 3500 available at www.fda.gov/Medwatch/getforms.htm and mail to Medwatch, 5600 Fishers Lane, Rockville, MD 20852-9787. Questions related to this notice should be directed to 303-501-8400 Monday through Friday, 8 a.m.to 5 p.m. MST. Zimmer Blomet

    Distribution

    Nationwide Distribution including Distributed nationwide to OH, LA, TX, and GA.

    Quantity

    7 parts