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Recall of Zimmer Biomet's Spinal Fusion Stimulators

May 31, 2017
Positive cytotoxicity test indicates higher levels of harmful chemicals in two of Zimmer Biomet's stimulators.

Zimmer Biomet has recalled the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to higher than allowed levels of potential harmful chemicals, "which may be toxic to tissues and organs, and that were found during the company's routine monitoring procedure," according to a release from the US Food and Drug Administration.

"The use of affected product may cause serious adverse health consequences, including but not limited to chronic infections, long-term hospitalization due to additional surgical procedures, paralysis, and death," warned the FDA.

The Zimmer Biomet Implantable Spinal Fusion Stimulators are used during spinal fusion surgery to increase the possibility of permanently connecting two or more bones of the spine together. The device is implanted into the patient's back and provides constant electrical stimulation to the surgical site.

Recalled Product:

  • Product Description: The SpF® PLUS-Mini (60μA/W) & SpF® SpF XL IIB Implantable Spinal Fusion Stimulators
  • Serial Numbers:
    • SpF-XL IIB: 224595, 224598, 224607, 224608, 224610, 224613, 224615, 224621, 224622, 224623, 224624, 224625, 224626, 224644, 224649, 224651, 224655, 224656, 224658, 224659, 224666, 224667
    • SpF-PLUS: 410093, 410094, 410096, 410103, 410111, 410115, 410119, 410148, 410151, 410158, 410171
  • Distribution Dates: March 28, 2017 to April 6, 2017
  • Manufacturing Dates: October 11, 2016 to January 18, 2017
  • Devices Recalled in the U.S.: 33

What To Do

On April 20, 2017 Zimmer Biomet sent an Urgent Medical Device Removal notification to all affected customers. The notice instructed customers to:

  1. Review notification and distribute the information to all appropriate personnel.
  2. Quarantine all affected products.
  3. The Zimmer Biomet sales representative will remove the affected product from the facility.
    • If the product was purchased directly from the company, follow the instructions on the Certificate of Acknowledgment form provided by Zimmer Biomet to complete the return. 
  4. Return the form to corporatequality.postmarket@zimmerbiomet.com or via fax to 574-372-4265.
  5. Retain a copy of the Acknowledgement Form with the field action records.
  6. Surgeons are reminded that normal clinical monitoring is recommended for 3-6 months post operatively for any patient with the affected devices implanted.

Customers of clinicians with questions related to this recall are instructed to contact Zimmer Biomet at 1-800-447-3625 or by email to corporatequality.postmarket@zimmerbiomet.com.

Last updated on: November 5, 2020
Continue Reading:
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