Zimmer Biomet recalls SpF PLUS-Mini, SpF XL IIb implantable spinal fusion stimulators — 5 insights

Spinal Tech

Zimmer Biomet recalled its SpF PLUS-Mini and SpF XL IIb implantable spinal fusion stimulators because of higher than allowed levels of potential harmful chemicals, Practical Pain Management reports.

Here's what you should know.


1. The FDA said in a release the chemicals could be toxic to tissues and organs.


2. The release says, "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."


3. Zimmer Biomet distributed the recalled devices between March 28, 2017 and April 6, 2017, and manufactured the devices between Oct. 11, 2016 and Jan. 18, 2017.


4. Zimmer Biomet recalled approximately 33 U.S.-based devices.


5. Zimmer Biomet sent a notice to all affected customers.


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