Product Recall Icelock Ratchet Medical Devices (ICN 2124)

MHRA TBC

NHS Supply Chain Reference: 08

Alert:

• The supplier Ossur has issued a Field Safety Notice recalling a range of Icelock Ratchet devices due to a lock release issue. The device is a mechanical lock used to connect and release a locking liner into a prosthetic socket. It is part of an external prosthetic system that replaces a missing lower limb.
• The attachment pin and lock can wear down faster than expected in the affected lot numbers due to a material compatibility issue. Worn or incompatible attachment pins can increase wear down of locks, even when used with a new lock.
• Faster wear can result in the potential for the pin to disengage from the lock, leading to loss of suspension, potentially leading to an injury.

Products Affected:

• Of the products that are affected by this recall, four are available from NHS Supply Chain:

• Please note, only the lot numbers listed in the Field Safety Notice are affected by this recall.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• If you have further distributed this product, please identify your customers, and notify them at once of this product alert.
• For affected lots in use, replace both lock body and attachment pin as soon as possible for users that have the following risk factors:
  • Trouble with socket fit due to volume changes in the residual limb.
  • Had lock replacement without having new attachment pin installed at the same time.
  • Have non-Össur attachment pin in use.
  • Complaint about loose fit of the socket or locking issues.
• For other users, replace the affected lots of lock body and attachment pin during the next planned consultation, such as liner replacement. If a user suggests there is an issue with the locking mechanism, the lock and attachment pin should be inspected for wear, regardless of lot number. Replace the lock and attachment pin if there are signs of wear; instructions for inspection of wear are attached.
• Inform applicable personnel handling the products about the added warnings in the Instructions for Use.
• Check your stock for unused affected devices and contact Ossur customer service by email: ukinfo@ossur.com or telephone: +44 (0)3450 065 06 to inform them of how many replacement devices are required.
• Please also contact your local NHS Supply Chain Customer Service Advisor with the details provided to Ossur to enable us to help in the event of any problems.
• Complete the acknowledgment form and return it to Ossur as soon as possible. See our Useful Links section to access the acknowledgement form.

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

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.