The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning SpF PLUS-Mini (60μA/W) & SpF SpF XL IIB Implantable Spinal Fusion Stimulators, manufactured by Zimmer Biomet. The affected devices are identified as follows:

• 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: 28 March 2017 to 6 April 2017
• Manufacturing Dates: 11 October 2016 to 18 January 2017

The manufacturer is recalling 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 (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.

On 20 April 2017, the manufacturer sent an Urgent Medical Device Removal notification to all affected users. The notice instructed affected users to:

• Quarantine all affected products.
• Surgeons are reminded that normal clinical monitoring is recommended for 3-6 months post operatively for any patient with the affected devices implanted.

Product removal is on-going.

According to the local supplier, the affected products are not distributed in Hong Kong.

For details, please refer to the FDA websites:
https://www.accessdata.fda.gov/scripts/ires/index.cfm#Event_77089
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm561044.htm
https://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm561004.htm

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 31 May 2017