What's the Problem?
The FDA on July 8, 2021, issued a Warning Letter  stating that NuVasive Specialized Orthopedics is recalling the following devices over potential bio-compatibility concerns:
Stainless Steel (Biodur 108)-Based Precice Devices:
- Precice Bone Transport
- Precice Plate
- Precice Stryde
Titanium-Based Precice Devices:
- Precice Freedom
- Precice Intra-medullary Limb Lengthening (IMLL) Device
- Precice Short
- Precice Unyte
"The FDA has received reports of pain and changes in the surrounding bone and soft tissue in people implanted with the Precice Stryde device, which is stainless steel (Biodur 108)-based," FDA said. "These adverse events may be related to corrosion, wear, and previously unanticipated exposure of components that are undergoing biocompatibility testing. At this time, the FDA is uncertain if the root cause of these adverse events is due to the stainless-steel material or related to design features and materials common to all Precice devices."
What are NuVasive Precice Implants Used For?
Precice devices are implants for those 18 years of age and older and are used to lengthen the limb, shorten or compress the limb or transport segments of long bones. They include adjustable rods that are placed inside a patient and are driven by an internal magnetic mechanism.
For patients implanted with any of the above devices, doctors should check for changes in the surrounding bone and soft tissue during routine radiographic monitoring.
When patients have increased pain or other unexpected symptoms, doctors should perform additional radiographs and physical examination, with special attention to the area surrounding the telescoping junction of the implant.
"At this time and based on currently available information, early removal of non-painful, well-functioning Precice devices from asymptomatic patients prior to one-year post implantation is not recommended," FDA said. "Decisions about removing or exchanging the Precice device should be made by health care providers in consultation with the patient or caregiver on a case-by-case basis."
Get a Free Precice Stryde Lawsuit Evaluation With Our Lawyers
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Precice Stryde Lawsuits. We are handling individual litigation nationwide and currently accepting new injury cases in all 50 states.
If you or a loved one was injured by a Nuvasive Precice device, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and our lawyers can help.