Recall of Zimmer Biomet’s Spinal Fusion Stimulators – May 31, 2017
Just when I thought electric stimulation could not possibly be damaging:
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.
How are “harmful chemicals” released by an electric stimulator? Nowhere in the article are the specific “harmful chemicals” listed.
“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.
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.
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:
- Review notification and distribute the information to all appropriate personnel.
- Quarantine all affected products.
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.
Return the form to firstname.lastname@example.org or via fax to 574-372-4265.
Retain a copy of the Acknowledgement Form with the field action records.
Surgeons are reminded that normal clinical monitoring is recommended for 3-6 months postoperatively 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 email@example.com.