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All Precice Systems by NuVasive Specialized Orthopedics Inc. (ICN 1194)

Important Customer Notice Field Safety Notice

Ref: 2021/1194 ICN Number: 1194

MRHA: 2020/012/009/226/001

NHSSC: 64

Alert: 

  • NuVasive Specialized Orthopedics, Inc. (NSO) has undertaken voluntary action to recall and suspend the supply of all Precice Systems to the UK while they are in the process of addressing the safety concerns identified by the MHRA.
  • A Field Safety Notice dated 20 January 2021 has been issued.
  • The MHRA’s letter which is in our Downloads ▼ section makes the following points:
    The long-term safety of the system family is unknown.
    Several biological endpoints have not been adequately assessed and others have failed to be considered, including chronic, reproductive and developmental toxicity, and carcinogenicity.”
    There has been widespread use of these devices in children and adolescents and that the Precice System has not been validated for use in these patient groups.

Products Affected:  

  • There are 580 eDirect NHS Supply Chain product codes affected.
  • The affected products have been suspended in our online catalogue and are currently not available to order.
  • Please refer to the Field Safety Notice and product listing for further information on the affected product codes.

Next Steps:    

  • Please see our Downloads ▼ section and read the MHRA’s letter and do not implant Precice System family devices until further notice.
  • Read and follow the full instructions in the Field Safety Notice and share this document with all users of the affected products.
  • Complete and return the consignee confirmation form on page 5 of the NuVasive Field Safety Notice to FSNprecice@nuvasive.com.
  • Upon receipt of the consignee confirmation form the supplier will arrange collection.
  • Please also advise your NHS Supply Chain Customer Service Advisor of actions taken to manage credit on your behalf.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.

Downloads ▼

  • 1194 NuVasive Field Safety Notice

    A PDF showing the Field Safety Notice for ICN 1194.
  • 1194 NuVasive MHRA Letter

    A PDF of the MHRAs Letter for ICN 1194.
  • 1194 NuVasive Product Listing

    An Excel file detailing the affected product codes for ICN 1194.
    Login to view the downloads