Product Recall Ossur Miami J Select PSA Hook Adhesion (ICN 2651)

MHRA TBC

NHSSC Ref: 40

Alert:

• Ossur has issued a Field Safety Notice recalling two Miami J Select Cervical Collars following discovery that the pressure sensitive adhesive (PSA) hooks attached to the sides of the anterior collar panel can occasionally exhibit poor adhesion.
• This may lead to them gradually peeling off with repeated use, potentially leading to reduced immobilization of the cervical spine. These hooks attach to straps on the posterior panel of the collar.
• Ossur advise that no immobilization issues or injuries associated with this fault have been reported to date.

Products Affected:

•  The products affected are available on the eDirect route from NHS Supply Chain:

• Please note only the Lot numbers quoted in Appendix A, page 4 of the Field Safety Notice are affected.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Quarantine all unused products with the affected Lot numbers.
• Complete and return the attached Customer Acknowledgement Form to: ukinfo@ossur.com
• Where you have products for collection by Ossur please also contact your local NHS Supply Chain Customer Service Advisor with full details of the affected products including NPC, Lot numbers and quantity to enable us to help if required.

Where Collars are already in use:

• If any of your customers are currently wearing a device, the packaging label should be inspected for the Lot number.
• If the Lot number is inside the affected range, healthcare professionals are advised to assess whether a removal and replacement of the impacted device currently in use is warranted on a case by-case basis.
• If the packaging label/Lot number is not available, healthcare professionals are advised to assess whether a removal and replacement of the impacted device currently in use is warranted on a case-by-case basis.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care Team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.