A series of bone growth stimulators have been issued a Class I recall by the U.S. Food and Drug Administration because they were improperly evaluated for bacteria and chemical residue prior to distribution.
Zimmer Biomet, Inc. recalled 1,360 units of its bone growth stimulators, stating “a lack of adequate validation and controls to ensure that final products were clean and free from bacteria and chemical residue.” This puts patients at risk of major health complications.
Patients who have been implanted with the following devices may be affected:
- 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 devices were manufactured between February 14, 2015 and April 11, 2017, and distributed between April 29, 2015 and March 31, 2018. All serial numbers that expire prior to March 31, 2019 are affected.
A bone growth stimulator works by sending a low level electrical signal to the body, which then stimulates bone growth (hence the name). Patients may be implanted with a bone growth stimulator when their body is unable to function and heal on its own.
Those who are implanted may have been treated for a spinal fusion surgery, suffered broken long bones (such as the legs and arms), or have a health condition that does not render adequate bone growth.
Potential side effects
The device can bring on a slew of health problems for those who are receiving therapy. The potential for side effects for a bacterial or chemical contamination include:
- Tissue death
- Impaired bone and wound healing
- Long-term antibiotic treatment
- Additional surgery
- Device removal
- Spinal cord infection or swelling (epidural abscess)
- Secondary gastroenteritis
Zimmer announced an Urgent Medical Device recall Notification Letter to its customers in February 2018. It outlined an action plan for various players in the healthcare industry (such as consignees, hospital risk managers, surgeons and distributors) to return or quarantine the device, and inform patients about the severity of the recall.
A Class I recall is the most serious type of recall issued by the FDA, as it may cause serious injury or death.
Questions About a Zimmer Bone Growth Stimulator Recall Lawsuit? Contact a Johnson//Becker Lawyer for a Free Case Review.
If you or a loved one has been affected by the above recalled products, you should contact our lawyers as soon as possible. Compensation may be available to you by filing a lawsuit against Zimmer Biomet, Inc.
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