Update on the NuVasive Specialized Orthopedics Precice device system
On the 5th April 2021, Nuvasive Specialized Orthopaedics (NSO), the manufacturer of Stryde and Precise implants, announced that the CE certification for all variations of the MAGEC and Precice device systems has been temporarily suspended.
This means that the sale of these products (including Precise-2 nail) are on hold in the European Union.
In addition, NSO voluntarily issued a ship hold on the MAGEC and Precice device systems worldwide in countries not requiring a CE Mark as the Company engages with local regulatory bodies.
You can see the latest announcement here: https://www.nuvasive.com/wp-content/uploads/2021/04/Company-statement_MAGEC-and-Precice-CE-Mark_09April2021.pdf
You can see all NSO’s Precise and Stryde related Field Safety Notices for the USA, European Union, UK, Australia and the rest of the world here: https://www.nuvasive.com/precicenotices/
Precise implants ( including Precise-2 nail) are not expected to be available for clinical use befre July or August 2021.
Following that, we inform you:
- All our scheduled cases relevant to these implants are postponed until the implants are available again.
- New cases with the use of these implants will be scheduled for the 24th August 2021 or later.
- In the meantime, the only available methods for limb reconstruction and lengthening cases in our centre will be external frames (Ilizarov, TSF, Monorail MRS) and combined methods (LATN, LON). You can learn more about these methods, here: https://www.athensbjr.com/methods-of-bone-fixation-in-limb-lengthening/
We sympathize with you for any inconvenience this development my be causing and remain at your disposal to help you explore alternative solutions for your condition. For more information, please contact: info@athensbjr.com