The FDA today released information on a Zimmer Biomet (NYSE:ZBH) recall of select SpF Plus-Mini and SpF XL IIB implantable spinal fusion stimulators over issues with potentially harmful chemicals which could be toxic to tissues and organs.
Class I recall designations, the agency’s most serious classification of recall, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death.
The SpF Plus-Mini and SpF XL IIB implantable spinal fusion stimulators are designed to be used to increase the possibility of permanently connecting 2 or more bones, and are implanted in a patient’s back to provide constant electrical stimulation to the surgical site, the Agency wrote.
The company is recalling the devices due to “higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs,” according to the FDA release.
The company said that they identified the issues during a routine monitoring procedure, and that use of an affected product could cause serious adverse health consequences including chronic infections, long-term hospitalizations requiring additional procedures, paralysis or death.
The recall affects approximately 33 select SpF Plus-Mini and SpF XL IIB implantable spinal fusion stimulators manufactured between Oct. 11, 2016 and Jan. 18, 2017 and distributed between March 28, 2017 and April 6, 2017. A total of 22 different serial numbers were identified for the SpF-XL IIB, and 11 with the SpF-Plus.
Zimmer Biomet instructed customers with the devices to quarantine all affected units and that a company rep would contact them to collect and remove them.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.