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
- 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.
- 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|
- 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: firstname.lastname@example.org 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.