Zimmer Biomet just issued a recall on its Implantable Spinal Fusion Stimulators over the devices’ potential to contaminate patients with harmful chemicals. The chemicals may be toxic due to the possibility of harmful chemicals that may be toxic to the body’s tissues and organs, according to the U.S. Food and Drug Administration (FDA).
Parker Waichman is investigating potential lawsuits on behalf of patients who were injured due to the Zimmer Biomet Implantable Spinal Fusion Stimulators, the SpF® PLUS-Mini (60μA/W) and SpF® SpF XL IIB Implantable Spinal Fusion Stimulators.
Zimmer Biomet Implantable Spinal Fusion Stimulators Recalled
The agency has deemed this action as a Class I recall, its most serious designation. A Class I recall means that use of the recalled product-in this case the Zimmer Biomet Implantable Spinal Fusion Stimulators-may lead to serious injuries or death.
The recalled Zimmer Biomet Implantable Spinal Fusion Stimulators’ product description is “The SpF® PLUS-Mini (60μA/W) and SpF® SpF XL IIB Implantable Spinal Fusion Stimulators.” The distribution dates were from March 28, 2017 to April 6, 2017 and the manufacturing dates were October 11, 2016 to January 28, 2017. A total of 33 devices were recalled in the United States and Zimmer Biomet sent an “Urgent Medical Device Removal” notification to all impacted customers. This letter was the precursor to the FDA’s recall designation. The involved serial numbers are:
- SpF-XL IIB: 224595, 224598, 224607, 224608, 224610, 224613, 224615, 224621, 224622, 224623, 224624, 224625, 224626, 224644, 224649, 224651, 224655, 224656, 224658, 224659, 224666, 224667
- SpF-PLUS: 410093, 410094, 410096, 410103, 410111, 410115, 410119, 410148, 410151, 410158, 410171
Zimmer Biomet has issued the recall of the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to a more-than-allowable level of potentially dangerous chemicals, which may be toxic to tissues and organs (cytotoxicity). These chemicals were found during the company’s normal monitoring procedure. A cytotoxicity test is a part of the biological evaluation of medical devices and is used to ensure compatibility with the device and the human body. A positive cytotoxicity test, which means that a failed result occurred, may indicate that a device contains potential harmful chemicals at amounts or levels that might be dangerous to the patient.
The use of the recalled Zimmer medical device may lead to serious adverse health consequences that include, but are not limited to, chronic infections, long-term hospitalization over required additional surgical procedures, paralysis, and death, noted the agency.
According to the FDA, health care providers using the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators and patients undergoing spinal fusion procedures involving the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators are impacted by the Class I recall.
The FDA indicated that, on April 20, 2017, Zimmer Biomet sent an “Urgent Medical Device Removal” notification to all of its affected customers. The notice instructed customers that:
- Zimmer customers are to review notification; distribute the information to all necessary personnel.
- Zimmer customers are to quarantine all affected recalled products.
- The Zimmer Biomet sales representative will remove the affected product from the facility. If the product was purchased directly Zimmer, Zimmer customers are to follow the instructions on the “Certificate of Acknowledgment” form provided by Zimmer Biomet to complete the return.
- Zimmer customers are to return the form by email or fax to Zimmer.
- Zimmer customers are to retain a copy of the “Acknowledgement Form” with the field action records.
- Surgeons are advised that normal clinical monitoring is recommended for three-to-six months post-operatively for any patient who has been implanted with any of the Zimmer Biomet recalled devices: The SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulators.
According to Zimmer Biomet, the SpF-XL IIb Implantable Spinal Fusion Stimulator and SpF PLUS-Mini Spinal Fusion Stimulator provide what Zimmer describes as “A Proven Adjunctive Treatment for Posterolateral Lumbar Spine Fusions.” Zimmer’s website indicates that, to date, over 100,000 of these devices have been implanted and the devices are meant to improve fusion success rates, particularly in patients with specific risk factors. The devices are meant to provide a constant dose of electrical stimulation for about six months.
What is the Purpose of Spinal Fusion?
According to Spine-Health.com, an internal bone growth stimulator is implanted during spinal fusion surgery. The device is small and implanted in a soft pocket of tissue under the skin in the lower back and to the side of spine. The device is meant to deliver small electrical currents directly to the area in the spine where bone growth/spine fusion takes place. The devices may be used with or without other devices related to the fusion.
The implanted device is often removed at the end of its useful life-six to 12 months following implantation. The small wires on top of the fusion site typically remain in the body.
Electrical bone growth stimulators are a supplemental type of therapy that assists in the enhancements to the body’s bone healing process, which is essential for the success of any type of spinal fusion surgery. Human bone is living tissue and, like skin, may be able to heal itself when broken or injured. Broken bone helps promote the body’s bone healing process by creating its own electrical field; therefore, use of an electrical stimulator is thought to enhance the body’s natural bone healing process, according to Spine-Health.com.
During spinal fusion surgery, multiple bone fragments must fuse (heal together) to create one solid bone. Bone fusion is not an immediately occurring process and takes place over time such as about six months, sometimes one year. Typically, the surgeon utilizes bone fragments that are generally taken from the iliac crest, which is inside of the patient’s hip, and placed in the area of the spine to be fused. Following the surgery, osteogenesis begins. Osteogenesis is a process in which the body grows bony tissue. After a few months to one year, the bone growth process usually unites the pieces of bone graft into a solid bone union.
The recalled Zimmer Biomet SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators are used during spinal fusion surgery. The Zimmer Biomet devices increase the potential of permanently connecting two or more bones of the spine. The Zimmer Biomet SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulator devices are implanted into the patient’s back and provide a constant electrical stimulation to the surgical site, which is what helps to unite the bone pieces.
In the event of toxin contamination when this type of surgical procedure is conducted the potential injuries are significant, sometimes deadly, which is why federal regulators have deemed the recall of the Zimmer Biomet SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators a Class I recall.
Filing a Zimmer Biomet SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators Injury Lawsuit
If you or someone you know is interested in filing a personal injury lawsuit over injuries associated with the Zimmer Biomet SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators, please contact the law firm of Parker Waichman LL today. Our firm offers free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).
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