Events

Recall of SpFXL IIB 2/DM Implantable Stimulator

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by EBI Patient Care, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77089
  • Event Risk Class
    Class 1
  • Event Number
    Z-2118-2017
  • Event Initiated Date
    2017-04-20
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154946
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Stimulator, invasive bone growth - Product Code LOE
  • 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 corporatequality.postmarket@zimmerbiomet.com.

Device

SpFXL IIB 2/DM Implantable Stimulator
  • Model / Serial
    Serial Numbers: 224595 224598 224607 224608 224610 224613 224615 224621 224622 224623 224624 224625 224626 224644 224649 224651 224655 224656 224658 224659 224666, and  224667.
  • Product Classification
    Orthopedic Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide distribution only.
  • Product Description
    10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. || Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
  • Manufacturer
    EBI Patient Care, Inc.

Manufacturer

EBI Patient Care, Inc.
  • Manufacturer Address
    EBI Patient Care, Inc., 484 Calle E, Guaynabo PR 00969-3454
  • Source
    USFDA