Zimmer Biomet, Inc. has recalled SpF® Implantable Spinal Fusion Stimulators and the Osteogen® Implantable Bone Growth Simulator due to a risk of bacterial or chemical contamination that could result in an infection, death, and other side effects.
Need a Texas Bone Growth Stimulator Recall Lawyer? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was diagnosed with a severe side effect of a recalled Zimmer bone growth or spinal fusion stimulator, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
Zimmer Recalls Bone Growth and Spinal Fusion Stimulators
Zimmer Biomet Inc. recalled about 1,360 implantable bone growth and spinal fusion stimulators due to a lack of assurance that final products were clean and free from bacteria and chemical residue, which could result in an infection.
In November 2018, the FDA identified this as a Class I recall, the most serious type of recall. Use of the device may cause serious injuries or death.
What Products Were Recalled?
Zimmer Biomet, Inc. is recalling the following devices:
- EBI Osteogen Implantable Bone Growth Stimulator
- SpF® PLUS-Mini (60 μA/W) Implantable Spinal Fusion Stimulator
- SpF®-XL IIb 2/DM Implantable Spinal Fusion Stimulator
The recall includes all serial numbers expiring prior to March 31, 2019. The products were manufactured between February 14, 2015 and April 11, 2017. They were distributed between April 29, 2015 and March 31, 2018.
FDA Finds Harmful Levels of Toxic Chemicals
The Zimmer Biomet SpF Bone Stimulator devices that were recalled may have toxic levels of harmful chemicals that could cause organ or tissue damage.
The FDA announced that “Zimmer Biomet is recalling the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators “due to higher than allowed levels of potential harmful chemicals…”
The FDA warned that “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.”
What is the Problem?
Zimmer recalled the bone growth stimulator implants “due to a lack of adequate validation and controls to ensure that final products were clean and free from bacteria and chemical residue.” The lack of adequate validation and controls may cause serious side effects.
What is the Risk?
- Infection
- Tissue death
- Additional surgery for wound treatment
- Surgery for device removal
- Impaired wound and bone healing
- Long-term antibiotic therapy
- Secondary gastroenteritis
- Swelling around the spinal cord
- Infection around the spinal cord (epidural abscess)
- Paralysis
- Organ damage
- Death
What Should I Do?
On February 19, 2018, Zimmer issued an “Urgent Medical Device Recall Notification Letter” to warn doctors about the potential risk.
Customers with questions may contact Zimmer Biomet, Inc. at 574-371-3071, Monday through Friday, from 8:00 AM Eastern Standard Time to 5:00 PM Eastern Standard Time, or email at CorporateQuality.PostMarket@zimmerbiomet.com.
Need a Zimmer Bone Growth Stimulator Recall Lawyer in Texas?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
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