Field Safety Notice Miami J Select Cervical Collars Potential Deformation of Chin Support GLD001 and GLD002 (ICN 1322)

Important Customer Notice Field Safety Notice

Ref: 2021/1322 ICN Number: 1322

NHSSC Ref: 34B

Alert:  

  • Ossur is implementing a Field Safety Corrective Action in relation to the Instructions for Use for the Miami J Select device. It has been identified that the Instructions for Use require additional information to facilitate the selection and use of the device.
  • To ensure compliance the Instructions for Use (Rev. 3 2018) have been updated to include the additional information required (Rev. 6 2021).
  • Ossur has not received any reports of injury related to the Miami J Select device.

Products Affected:

  • These products are available from NHS Supply Chain:
NPC Product Description Supplier Code/ MPC Supply Route
GLD001 Cervical collar Miami J Select with replacement pads MJSR-101 eDirect
GLD002 Cervical collar Miami J Select MJS101 eDirect

Next Steps:

  • Please ensure the updated Instructions for Use are distributed to the necessary persons within your organization and that they are adhered to when selecting and using the Miami J Select device. A copy of the updated instructions accompanies this notice.
  • Please pass this notice to those who need to be aware within your organisation or to any organisation where the listed devices have been transferred.
  • Please retain this letter in a prominent position for one month.
  • Complete and return the Customer Acknowledgement Form (see our Downloads ▼ section. by email to: ukinfo@ossur.com even if your facility is no longer in possession of a Miami J Select device as Ossur require this information to reconcile this process.

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

Downloads ▼

  • 1322 Customer Acknowledgement Form

    A PDF of the Customer Acknowledgement Form for ICN 1322.
  • 1322 Field Safety Notice

    A PDF of the Field Safety Notice for ICN 1322.
  • 1322 Instructions For Use

    A PDF of the Instructions For Use for ICN 1322.