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

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.