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.
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:
- 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)
- Organ damage
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