BEUDAMED
    FDA Recall Terminated

    Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.

    Recall: Z-1943-2016 · Initiated May 11, 2016

    Recall

    Recall Number
    Z-1943-2016
    Event Number
    74172
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    May 11, 2016
    Posted
    June 9, 2016
    Terminated
    March 10, 2017
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bony voids or defects of the extremities and pelvis that are not instrinsic to the stability of the bony structure.

    Reason

    DePuy Synthes is initiating a voluntary medical device recall of unexpired and unopened part and lot numbers for the Norian Drillable Injects-Sterile due to the rotary pouch within the referenced lots and associated part numbers may potentially be labeled with the incorrect powder volume/size; however, the rotary pouch contains the correct powder volume/size according to the outer label.

    Action

    DePuy Synthes sent an Urgent Medical Device Recall letter dated May 9, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers with the affected products were asked to call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product(s), Complete the Verification Section (page 3 of this letter) and Return the Verification Section (page 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Send a copy of the completed Verification Section by:Fax: 855-695-8597 or Scan/email: [email protected]. If they had any questions they were asked to call 610-719-5450. For questions regarding this recall call 610-719-5443.

    Distribution

    Worldwide Distribution - Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD., ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, UT, VA, VT, WA, WI, WV, WY and Internationally to Canada...

    Quantity

    2812 units