Zimmer Biomet Spinal Fusion Stimulators Recalled
Walter Eisner • Fri, June 2nd, 2017
On April 20, 2017 Zimmer Biomet Holdings, Inc. sent an Urgent Medical Device Removal notification to all affected customers implanted with SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators.
The 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.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
The devices were distributed between March 28, 2017 to April 7, 2017 and manufactured between October 11, 2016 to January 18, 2017.
According to the FDA, the recall is due to "higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs (cytotoxicity) and that were found during the company's routine monitoring procedure. A cytotoxicity test is a part of the biological evaluation of medical devices to ensure compatibility with the device and the human body. A positive cytotoxicity test (failed result) can indicate that a device contains potential harmful chemicals at amounts or levels that could be dangerous to the patient."
"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."
The SpF® PLUS-Mini (60µA/W) & SpF® SpF XL IIB Implantable Spinal Fusion Stimulators
- 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
Customers with questions related to this recall are instructed to contact Zimmer Biomet at 1-800-447-3625 (Monday - Friday, 8 am - 5 pm Mountain Standard Time) or by email to email@example.com.
Customers are instructed 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 post operatively for any patient with the affected devices implanted.
Adverse reactions or quality problems using these devices should be reported to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178.
The Biomet website states the concept of using electrical stimulation to affect bone growth began with Julius Wolff over 100 years ago. Thirty years ago, all the research that had been done on the response of bone to electrical stimulation led to Dwyer’s development of the first implantable bone growth stimulator for lumbosacral fusion.
Since that time, says the company, many studies have conclusively demonstrated the efficacy of direct current stimulation improving the success rate of spinal fusions.
“The SpF Implantable Spinal Fusion Stimulator maximizes surgeon convenience and patient comfort, minimizes risk, is cost effective and is a proven adjunct to the spinal fusion procedure."
To read the Biomet Surgical Technique guide, click here.