Precice Stryde, Plate, and Bone Transport Systems Recall
An Alert from the International Center for Limb Lengthening (ICLL) of the Rubin Institute for Advanced Orthopedics (RIAO) – March 3, 2021
Recall for NuVasive Precice Stryde, Plate, and Bone Transport Systems
We want to share with our RIAO ICLL patients and families that NuVasive has issued a voluntary field recall of their Precice Stryde, Precice Plate and Precice Bone Transport systems. These are their newer products, all of which are made from stainless steel. This recall does not impact the original titanium Precice internal lengthening nail systems. Patients who already have the stainless-steel devices implanted should continue to lengthen as planned; we will use our normal protocols to monitor patients’ bones during the lengthening and healing period. We will also follow our normal routine to remove these lengthening implants about one year after their insertion.
Why is there a recall?
There have been some issues observed with the Precice Stryde nail, where a small number of patients experienced pain and/or bony abnormalities at the interface between the telescoping nail segments. The bony abnormalities observed are generally small erosions on the inner bone around that segment of the nails. The root cause has yet to be confirmed and is being actively researched. There have been no reported issues with the new Precice Plate or the Precice Bone Transport systems. However, out of an abundance of caution, and because the Precice Plate and Bone Transport systems are also made of stainless steel, they are also temporarily on hold.
Please note this is a voluntary recall; NuVasive is taking extra precautions to ensure the safety of their implants. Studies are being done to assess biological safety issues, and it is projected that they will be completed by the end of September 2021. It is anticipated that once additional testing is completed, the company will work together with the FDA to return these products to market.
What is our current policy?
We cannot implant new Precice Stryde, Plate, or Bone Transport systems until the studies are completed, and it is determined to be safe to proceed. If you have surgery scheduled to receive any of these systems, your care team will contact you soon.
For patients who have Stryde and other stainless-steel implants, you will receive a letter from us soon. We will continue lengthening as planned and our normal practice of removing the implants after one year, provided the bone is fully healed. We will follow our normal protocol of monitoring the bones during lengthening and healing.
Can I still have a Precice Nail for my lengthening?
This voluntary field safety recall does not include the Precice titanium devices, so we are continuing to implant the original titanium Precice lengthening nails. We will follow our normal routine of monitoring and removal.
If you have any questions about your care or your implant, we encourage you to contact your surgeon by email. We will also periodically update our RIAO ICLL family of patients through our social media platforms.