BEUDAMED
    FDA Recall Terminated

    10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.

    Recall: Z-2119-2017 · Initiated April 20, 2017

    Recall

    Recall Number
    Z-2119-2017
    Event Number
    77089
    Firm
    EBI Patient Care, Inc.
    FEI Number
    3003435252
    Product Code
    LOE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 20, 2017
    Posted
    May 26, 2017
    Terminated
    October 17, 2018
    Address
    484 Calle E, Guaynabo, PR, 00969-3454

    Description

    10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.

    Reason

    Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.

    Action

    An Urgent Medical Device Recall letter, dated April 20, 2017, was sent to the firm's consignees. The letter identified the affected product and the reason for the recall, as well as the risks involved. Consignees were instructed to quarantine affected product in their inventory and complete the Certification of Acknowledgement portion and the Inventory Return Certification Form in the letter. Affected product must be returned immediately along with the completed Inventory Return Certification Form. Questions or concerns should be directed to the customer call center at 1-800-447-3625 or via email to [email protected].

    Distribution

    Nationwide distribution only.

    Quantity

    33 units total