BEUDAMED
    FDA Recall Terminated

    SpF PLUS-Mini (60 A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    Recall: Z-0287-2019 · Initiated February 19, 2018

    Recall

    Recall Number
    Z-0287-2019
    Event Number
    81127
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1000220733
    Product Code
    LOE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 19, 2018
    Terminated
    August 25, 2020
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    SpF PLUS-Mini (60 A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels

    Reason

    Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.

    Action

    The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 2/22/2018 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to [email protected]. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].

    Distribution

    US Nationwide Distribution: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV ; and country of: Australia.

    Quantity

    4,879 units (2,982 units have been implanted and 537 have been scrapped)