Field Safety Notice Heraeus Medical PALACOS® and COPAL® pro Systems Ready to Mix Bone Cement (ICN 3476)

NHS Supply Chain Reference: 61

Alert:

• Heraeus Medical has issued Field Safety Notice 201281227 following isolated reports of monomer liquid leaking from the pro system.
• Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix) is used for stable anchoring of total or partial joint endoprostheses in living bone.
• If monomer liquid leaks from the pro system, it may come into unintended contact with the user’s skin or eyes. In the event of eye contact, there is a risk of temporary irritation, redness, a burning sensation or other local symptoms, which may require medical attention.

Products Affected:

• Seven products are affected.
• The seven products affected are available via NHS Supply Chain’s eDirect service.
• Please refer to the product listing for full details.
• Heraeus advise their assessments carried out to date have shown that the affected product can continue to be used as intended. Only the product that has leaked needs to be discarded.
• There is no need to exchange or return the product.

Next Steps:

• Eye protection control information is already part of the PALACOS® and COPAL® pro safety data sheets. Nevertheless, the company has decided to expand the safety precautions as an additional layer of protection in the Instructions for Use.
• The updated recommendation will be included in the next revision of the Instructions for Use.
• Until this updated documentation is available, users are advised to follow the measures described in the Field Safety Notice.
• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• This includes ensuring suitable eye protection is worn whenever the system is being operated, in accordance with the applicable health and safety regulations.
• Complete and return the Customer Reply Form, page 4 of the field safety notice, and email to Hm.fsca.medical@heraeus.com within five (5) calendar days of receiving these instructions.
• This form should be returned even if you are no longer using the product.

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