Regulators issue urgent recall over “toxic” spinal fusion stimulators

Regulators have issued a top-level recall over Zimmer Biomet SpF spinal fusion stimulators amidst concerns that the medical devices contain chemicals that can seriously harm patients, and even be fatal.

This is a serious recall given there is a reasonable probability that using a certain defective product can serious injure or kill the patient. It’s reported that 33 affected units were manufactured and distributed.

The affected stimulators are the SpF-XL IIB (22 units) and the SpF- Plus (11 units)

The devices were manufactured between 11^th October 2016 and 18^th January 2017, and distributed between 28^th March 2017 and 6^th April 2017.

Marketed as “innovation that stands the test of time” by Zimmer, the spinal fusion stimulators were created to help two or more spinal bones to reconnect permanently. The stimulant is injected into the spine for contrast electrical stimulation during surgery. According to Zimmer, the medical devices have been implanted over 100,000 times as proof of its successful clinical history. Unfortunately, the 33 affected units could result in serious injury or even death for patients.

Patients could be at risk of harm

Manufacturer Zimmer Biomet said that the problem was identified during routine checks on the medical device. Cytotoxicity tests are carried out to check whether a device is compatible with the human body. They believe the adverse health consequences can include:

“Toxic to tissues and organs”

It’s reported that the stimulator devices contain chemicals that could prove to be “toxic to tissues and organs”. Health care providers who implant the devices may also be adversely affected as they come into contact with the stimulators carrying the dangerous chemicals.

Zimmer Biomet are instructing all customers, health providers and suppliers to quarantine affected units. A company representative is to contact stockists for the recall, and clinical monitoring for up to six months is highly recommended for patients implanted with the device.

Zimmer no stranger to controversy

The medical device manufacturer is reportedly no stranger to controversy in medical news. Only last year, Zimmer Biomet were found to have violated several safety regulations at one of its facilities in Warsaw, Indiana.

Regulators demanded the company clean up its act to bring the plant into compliance. Zimmer informed regulators last month that it had changed five of its operations and quality executives in addition to cleaning up the facility.

Manufacturers of medical devices must ensure they comply with relevant health and safety regulations, and conduct regular and thorough testing of their products. As this article highlights a defective product can lead to serious harm for patients.