Field Safety Notice Zimmer Biomet NexGen LCCK Articular Surface with Locking Screw Products FJE4296 and FQN5777 (ICN 2819)

NHSSC: 88

Alert:

• Zimmer Inc. is conducting a batch specific medical device Field Safety Corrective Action (removal) for seven batches of the NexGen LCCK Articular Surface with Locking Screw products.
• The supplier identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled incorrectly.
• The non-conforming units were assembled with a metal support post that is shorter than expected, leading to a portion of the polyethylene spine being unsupported.
• To date, the supplier has received no product complaints.

Products Affected:

• The two affected products are available via NHS Supply Chain eDirect route:

•  The affected products were distributed between May 2024 and December 2024.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine the affected Lot numbers.
• Complete the Certificate of Acknowledgement, found on page three of the notice, and return to uk@zimmerbiomet.com
• The supplier will arrange collection of the affected goods.
• Once the affected products have been collected, please contact your local NHS Supply Chain Customer Service Advisor with the details to allow us to raise the appropriate credit on your behalf.

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.