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Zimmer Bone Stimulator Lawsuit

Zimmer Bone Stimulator Lawsuit

Zimmer Biomet Inc. recalled the Osteogen® Implantable Bone Growth Simulator and the SpF® Implantable Spinal Fusion Stimulator due to a risk of contamination, infection, death, and other serious side effects.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Zimmer bone growth and spinal fusion stimulator induced injury cases in all 50 states. If you or somebody you know had an infection or other serious injury, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Zimmer Recalls Bone Growth and Spinal Fusion Stimulators

In February 2018, Zimmer Biomet Inc. announced a recall for 1,360 implantable bone growth and spinal fusion stimulators because they may be contaminated with bacterial or chemical residue, which could lead to an infection.

In November 2018, the FDA identified this action as a “Class I recall,” which is the most serious type of recall, reserved for devices that may cause serious injury or death.

What Products Were Recalled?

Zimmer Biomet recalled 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 Serial Numbers that expire before March 31, 2019. The y were manufactured between February 14, 2015 and April 11, 2017 and distributed from April 29, 2015 through March 31, 2018.

FDA Finds High Levels of Toxic Chemicals

The recalled Zimmer Biomet SpF Bone Stimulator may have dangerous levels of toxic chemicals that could damage organs or tissues, according to the FDA.

The FDA warned 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…” 

Furthermore, the FDA said 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?

The FDA warned that Zimmer did not have adequate validation and controls to be sure that the final devices were clean and free from bacteria and chemical residue. This may cause serious side effects.

What is the Risk?

The potential side effects of implanting a non-sterile bone growth stimulator may include:

  • 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?

Zimmer warned doctors about the potential risk in an “Urgent Medical Device Recall Notification Letter” in February 2018.

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

Do I have a Zimmer Bone Growth Stimulator Lawsuit?

The Schmidt Firm, PLLC is currently accepting Zimmer bone growth and spinal fusion stimulator induced injury cases in all 50 states. If you or somebody you know had an infection or other serious injury, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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No matter what type of case you have, you may contact us with confidence by filling out the email contact form below or calling us directly by dialing toll free 24 hrs/day (866) 920-0753.

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