NuVasive Specialized Orthopedics has recalled its Precice System devices used in limb lengthening or shortening procedures and long bone transports due to the risk of biocompatibility issues, which may result in bone and soft tissue changes around the implant site. If you received a NuVasive Precice System implant and you are experiencing pain or bone changes around the implant, you may be entitled to compensation. Contact Consumer Safety Watch today to find out how we can help.
Patients who have received a NuVasive Precice implant and are currently experiencing pain or other complications may be entitled to compensation for their injuries. The FDA has warned about the potential risk of side effects associated with NuVasive Specialized Orthopedics’ Precice System and has urged healthcare providers to watch for changes in the surrounding bone and soft tissue in patients implanted with the recalled devices.
The reason for the NuVasive Precice System recall has to do with concerns about biocompatibility, which refers to how compatible the materials used in a medical device implant are with living tissue. Materials that are biocompatible perform as expected and do not produce any harmful physiological effects when they come into contact with the body. On the other hand, medical devices that have not been properly tested for biocompatibility pose a risk of adverse events and could end up causing serious harm to patients implanted with those devices. According to the FDA, the biocompatibility issues associated with the Precice devices may be related to “corrosion, wear, and previously unanticipated exposure of components that are undergoing biocompatibility testing.”
• Pain and discomfort
• Bone or soft tissue changes around the implant
• The need for surgery to remove or replace the device
“In early July 2021, the FDA issued a letter notifying healthcare providers about the potential biocompatibility concerns associated with NuVasive’s Precice devices. At that time, the agency had received reports “describing pain and changes in surrounding bone and soft tissue in patients with the stainless steel-based Precice devices,” a problem the FDA noted could be attributed to the devices’ stainless-steel material or other design features that are present in all Precice System devices. “
The Precice System manufactured by NuVasive Specialized Orthopedics is an implant used for lengthening a limb, shortening or compressing a limb, fracture fixation, or transporting segments of long bones in adults 18 years of age and older. The medical devices are made from stainless steel and titanium and feature an internal magnetic mechanism and screws and nails that, once implanted, can be adjusted using an external remote controller. The Precice System was designed to replace external fixation devices and eliminate the need for shortening of the healthy limb in patients with a limb length discrepancy. In patients who receive a Precice device for limb lengthening, an intramedullary nail is implanted in the femur, tibia or humerus. The remote controller is then programmed to slowly lengthen the nail, which lengthens the bone, until the desired limb length is reached.
Stainless Steel (Biodur 108)-Based Precice Devices:
• Precice Bone Transport
• Precice Stryde
• Precice Plate
Titanium-Based Precice Devices:
• Precice Short
• Precice Freedom
• Precice Intra-medullary Limb Lengthening (IMLL) Device
• Precice Unyte
As of February 2021, all stainless steel-based Precice devices were removed from the market in the U.S. due to a potential risk of pain and bone changes in patients implanted with the medical devices. The Precice recall was issued based on adverse event reports from patients describing increased pain, discomfort, and changes in the bone or soft tissue around the implantation site. On April 5, 2021, NuVasive placed a global ship hold on all Precice implants and posted a statement notifying healthcare providers about ongoing biocompatibility testing for Precice System implants.
In early July 2021, the FDA issued a letter notifying healthcare providers about the potential biocompatibility concerns associated with NuVasive’s Precice devices. At that time, the agency had received reports “describing pain and changes in surrounding bone and soft tissue in patients with the stainless steel-based Precice devices,” a problem the FDA noted could be attributed to the devices’ stainless-steel material or other design features that are present in all Precice System devices.
Based on the risk of adverse events, the FDA has recommended that healthcare providers stop implanting any new stainless steel-based Precice devices in patients. And while there are no known reports of adverse events involving potential biocompatibility issues with the titanium-based Precice devices, the titanium devices have been recalled by NuVasive, and due to the manufacturer ship hold, are not being sold in the U.S.
