The stainless steel Precice Stryde nail, made by NuVasive Specialized Orthopedics, was recalled from the U.S. market. The recall followed adverse events tied to potential biocompatibility concerns. Patients and clinicians have reported pain and bone changes around the nail.
No MDL or class action is listed for the Precice Stryde, and no public court docket names it. The FDA also lists an open recall of Precice Max, posted in November 2024.
The FDA says stainless steel Precice devices, including the Stryde, Plate and Bone Transport, should not be implanted. It continues to monitor titanium Precice devices.
- Case or litigation name: No MDL or class action
- Defendants: No defendant named in a public court docket
- Court and docket number, when available: No public court docket
- MDL number, judge, and case count, when an MDL exists: No MDL
- Filing date: No public filing
- Main allegations: Pain, bone erosion and other bone changes around stainless steel Precice nails, reported to the FDA and in clinical studies and linked by the FDA to potential biocompatibility concerns
- Products or people involved: Precice Stryde, Precice Plate and Precice Bone Transport (stainless steel); Precice Max (Class 2 recall, 164 devices); people who had a Precice limb-lengthening nail implanted
Table Of Contents
- Latest Precice Stryde Lawsuit Updates
- November 21, 2024: FDA Posts Class 2 Recall of Precice Max
- June 28, 2023: FDA Updates Letter to Health Care Providers
- December 1, 2021: NuVasive Publishes Statement on Titanium Devices
- November 30, 2021: NuVasive Lifts Ship Hold on Titanium Devices
- July 8, 2021: FDA Issues Letter on Biocompatibility Concerns
- March 3, 2021: Limb Lengthening Center Alerts Patients to Recall
- February 4, 2021: Danish Medicines Agency Releases NuVasive Safety Notice
- What Is Precice Stryde?
- Who May Be Affected?
- Reported Injuries or Damages
- Recall and Regulatory Background
- Evidence to Preserve
- Filing Deadlines
- Frequently Asked Questions
- References
Latest Precice Stryde Lawsuit Updates
November 21, 2024: FDA Posts Class 2 Recall of Precice Max
The FDA posted a Class 2 recall of Precice Max in its device recall database. The recall number is Z-0500-2025, and the firm began the recall on September 30, 2024 [1].
The record covers 164 devices distributed in Florida and Nevada. It lists the recall as open. The recall notice names Globus Medical as the contact for customers.
June 28, 2023: FDA Updates Letter to Health Care Providers
The FDA update letter to health care providers covers Precice devices made by NuVasive Specialized Orthopedics. The update followed a March 2023 510(k) clearance for expanded use [2].
In the update, the FDA said it continues to monitor adverse events tied to biocompatibility concerns with the titanium Precice devices.
December 1, 2021: NuVasive Publishes Statement on Titanium Devices
The NuVasive statement quotes the FDA on the titanium Precice devices. The statement says the overall benefits of the devices outweigh the known risks for on-label use with the updated labeling [3].
November 30, 2021: NuVasive Lifts Ship Hold on Titanium Devices
The NuVasive surgeon letter of November 30, 2021 says its U.S. voluntary ship hold on the titanium Precice Unyte and Precice Freedom was lifted [4].
The Precice Stryde, Precice Bone Transport and Precice Plate had been removed from the market earlier. The letter says they remained unavailable.
July 8, 2021: FDA Issues Letter on Biocompatibility Concerns
The FDA issued a letter to health care providers about potential biocompatibility concerns with Precice devices made from stainless steel and titanium.
March 3, 2021: Limb Lengthening Center Alerts Patients to Recall
The International Center for Limb Lengthening at Sinai Hospital of Baltimore alerted patients. The ICLL alert says NuVasive had issued a voluntary field recall of the Precice Stryde, Plate and Bone Transport systems [5].
The center said it would continue lengthening as planned. It would remove the implants after one year, provided the bone is fully healed.
February 4, 2021: Danish Medicines Agency Releases NuVasive Safety Notice
The Danish Medicines Agency released an urgent field safety notice from NuVasive on the Stryde and all Precice system devices, according to Rolfing et al., whose Danish nationwide study appeared in Acta Orthopaedica on March 24, 2021 [6].
What Is Precice Stryde?
According to Reif et al. in Strategies in Trauma and Limb Reconstruction (2023), the Precice Stryde nail was introduced in 2018. It is made of a stainless-steel alloy, Biodur 108, instead of titanium [7].
It increased weight-bearing up to 250 pounds (113 kg). The FDA describes Precice devices as implants with adjustable rods placed inside a patient, driven by an internal magnetic mechanism.
Who May Be Affected?
People with a stainless steel Precice Stryde, Plate or Bone Transport nail may be affected. A 2023 cohort study reports that one center implanted 90 Stryde nails in 63 patients from January 2019 to February 2021.
People with a titanium Precice device, which the FDA continues to monitor, may also be affected. Patients who received a Precice Max device distributed in Florida and Nevada fall under the open recall.
The FDA lists the Precice IMLL for limb lengthening of the femur and tibia in patients over 12. Whether a person qualifies for any claim depends on an individual legal review of their facts.
Reported Injuries or Damages
Clinicians have reported pain and bony abnormalities in Stryde patients. They occur where the telescoping nail segments meet. The International Center for Limb Lengthening alert calls them small erosions of the inner bone. It says the cause is not confirmed.
The 2023 Stryde cohort study reported radiographic changes in 66 bones (73%). Late-onset pain occurred in 11.1% of nails, and all pain resolved. The authors found the changes did not affect bone healing in the femur.
The Danish study by Rolfing et al. (2021) saw radiographic changes in 21 of 30 segments and discoloration, a possible sign of corrosion, in many removed nails.
The FDA’s June 28, 2023 letter ties the stainless steel recall to adverse events. It cites potential biocompatibility concerns. NuVasive continues to investigate the root cause. Reports like these do not prove a device caused every injury.
Recall and Regulatory Background
Stainless steel Precice devices (Stryde, Plate and Bone Transport) were taken off the U.S. market in a voluntary NuVasive field recall in early 2021. They remain recalled, the FDA’s June 28, 2023 letter says.
A recall does not prove liability, and no MDL or class action is listed for these devices. Schmidt & Clark covers other medical device lawsuits.
Evidence to Preserve
Keep any records tied to the implant and your care. These items help show which device you had:
- The implant name, model, lot or serial number and implant date, from the operative report or implant card.
- Operative notes, X-rays and follow-up imaging.
- Records of pain, swelling, infection, a broken nail or surgery to remove it.
- Medical bills and records of time away from work.
- Letters or notices about the device from your surgeon, hospital or maker.
- Photos of any removed device and any written messages with the clinic or manufacturer.
Filing Deadlines
Filing deadlines come from state law. They vary with where a person lives and when the injury, the device removal and the diagnosis happened.
Some states start the clock when the problem is discovered. Missing a deadline can end a claim even when the facts are strong, so check with a lawyer promptly.
Frequently Asked Questions
What Was the Precice Max Recall?
The Precice Max recall cited potential issues with design, manufacturing and documentation related to validation of the affected devices. The FDA lists the cause as under investigation by the firm. Customers can contact Globus Medical at recall@globusmedical.com or 1-866-456-2871.
What Does the Research Say About Precice Stryde Nails?
Research on Precice Stryde nails reports bone changes. In the 2023 cohort, late-onset pain affected eight patients, or 12.7% of patients. In the Danish study of 27 patients, osteolysis appeared in 19 of 30 segments.
How Long Does It Take to Recover from Precice Nail Surgery?
Recovery time after Precice nail surgery is not given as one figure. Care teams remove the implants once the bone is healed. In the one-center Stryde study, femur healing took 29.6 days per cm with changes and 29.4 without.
Is the FDA Recommending Removal of Precice Devices?
Yes, the FDA reminds providers to follow the Instructions for Use and to remove the Precice device after one year. It also says not to implant the device in patients under 50 pounds, or more than two Precice devices at once.
Where Do I Report a Problem with a Precice Device?
Report a problem with a Precice device through MedWatch, the FDA Safety Information and Adverse Event Reporting program, which takes voluntary reports. The FDA encourages health care providers to report adverse events with NuVasive Precice devices. Its information line is 1-888-463-6332.
Are Titanium Precice Devices Recalled?
The FDA letter describes only the stainless steel Precice devices as recalled. The FDA said it is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices.
References
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=210611
- https://www.fda.gov/medical-devices/letters-health-care-providers/update-nuvasive-specialized-orthopedics-precice-devices-letter-health-care-providers
- https://www.globusmedical.com/wp-content/uploads/2025/05/NuVasive-statement_Precice-titanium-availability_01Dec2021_Final.pdf
- https://www.globusmedical.com/wp-content/uploads/2025/05/Surgeon-letter_Precice-titanium-U.S.-availability_30November2021_Final.pdf
- https://www.limblength.org/recalls/precice-stryde-plate-and-bone-transport-systems-recall/
- https://pmc.ncbi.nlm.nih.gov/articles/PMC8428270/
- https://pmc.ncbi.nlm.nih.gov/articles/PMC10628610/