Skip to main content

Supply Issues Heraeus Medical Bone Cement Products (ICN 3261)

Important Customer Notice Status Update Type Supply Disruption

Ref: 2026/3261 ICN Number: 3261

Situation overview

  • We were informed by our supplier, Heraeus Medical, on 16 February 2026 of a packaging fault affecting their bone cement products. This issue has temporarily halted production at their main site and will impact product availability for several months.
  • We have established an incident team and are working closely with Heraeus Medical.
  • We are coordinating with the Department of Health and Social Care and NHS England to manage the situation nationally. As part of this national response, National Clinical Directors in these areas are involved.
  • See our Downloads ▼ section for national guidance for clinicians issued jointly by NHS England’s National Clinical Directors and the British Orthopaedic Association. Trusts and ICBs should follow the guidance within the document and on elective procedures.
  • NHS Supply Chain has identified two clinically assured suitable alternatives that can be provided in the quantities and timeframe required to respond to this supply disruption.
  • The Zimmer Biomet Hi Fatigue G product is an ambient item and has been brought into stock exclusively through NHS Supply Chain. Sufficient quantities are available, and a clinician training video can be accessed via our Useful Links section to support the use of this alternative product.
  • The Johnson & Johnson CMW Smartset GHV Gentamicin is an existing catalogue product available through NHS Supply Chain, with additional quantities now secured to support customers who previously ordered Heraeus products This is a cold-chain item so will continue to be delivered via our eDirect route. Once delivered the product should be stored as an ambient product.
  • All existing bone cement products from suppliers other than Heraeus are available to order as normal, including Zimmer Biomet’s existing Refobacin R high viscosity bone cement.
  • We continue to work closely with Heraeus and alternative suppliers to secure other available stock. Suppliers with stock are being asked to apply demand management measures to support the national stock position. Use will be prioritised in line with NHS England pathway guidance, with a particular emphasis on prioritising trauma care.
  • We will share further updates as soon as more information becomes available.

Next steps:

  • See our Downloads ▼ section  to read a customer briefing which sets out the products available and the way to order them, including demand capture and escalation processes. Please ensure you follow these processes.
  • See our Downloads ▼ section to find a series of information sheets to support clinical decision making over the use of the alternative products.
  • Follow the national guidance issued by NHS England and the British Orthopaedic Association to support local decision making on stock availability and elective procedures.
  • Check this ICN regularly for further updates.
  • See our Downloads ▼ section to view our Zimmer Biomet High Fatigue G Bone Cement Mixing Guidance. 
  • See our Downloads ▼ section to obtain a demand capture or escalation form
  • If you have any questions, please speak to your customer service advisor or your ICS Manager for further support.

Change

  • We are working closely with Heraeus on their recovery. The validation phase of manufacturing is ongoing, and as such the manufacturing of product has not yet commenced. The lead time from manufacturing to finished product is approximately eight weeks.
  • We will update this ICN once Heraeus confirms that production has restarted at scale and will provide firmer timelines as soon as they are reviewed and agreed with Heraeus.
  • Please ensure quantities ordered for alternatives are for your immediate requirements and in line with national guidance.

Impact

  • We remain in a national supply disruption classified as an incident. Demand management measures are in place to ensure fair allocation nationally and continuity of patient care across the NHS.

Next steps

  • Regular updates and trust action will be shared on this ICN.

 

Download our publications ▼

  • 3261 Heraeus Medical Product Listing 18 February 2026

    An Excel file showing the product listing for ICN 3261.
    Login to view the downloads
  • 3261 Heraeus Medical Vancogenx Instructions for Use 19 March 2026

    A PDF showing the Vancogenx Instructions for Use for ICN 3261.
  • 3261 Heraeus Medical Vancogenx Product Information 19 March 2026

    A PDF showing the Vancogenx product information for ICN 3261.
  • 3261 Heraeus Medical NHS England Guidance 19 February 2026

    A PDF showing the NHS England guidance for ICN 3261.
  • 3261 Heraeus Medical NHS England Guidance Appendix 1 19 February 2026

    A PDF showing the NHS England guidance for ICN 3261.
  • 3261 Heraeus Medical Customer Letter 17 February 2026

    A PDF showing the customer letter for ICN 3261.
  • 3261 Zimmer Biomet Hi-Fatigue G Bone Cement-Mixing Chart

    A PDF showing both vacuum mixing and manual mixing of G Bone Cement for ICN 3261.
  • 3261 Zimmer Biomet Hi-Fatigue Evidence R Brochure

    A PDF showing evidence for Zimmer Biomet Hi-Fatigue cement for ICN 3261.
  • 3261 Zimmer Biomet Hi-Fatigue Bone Cement Instructions for Use (IFU)

    A PDF showing the instructions for the Zimmer Biomet Hi-Fatigue bone cement for ICN 3261.
  • 3261 Zimmer Biomet Hi-Fatigue and Optivac Brochure

    A PDF showing the Hi-Fatigue G Bone Cement and Hi-Fatigue bone cement with optivac vacuum mixing system for ICN 3261.
  • 3261 Hi-Fatigue Evidence Summary Appendix 1 - P. Jorgensen et al

    A PDF showing a report on Hi-Fatigue bone cement by P. Jorgensen et al for ICN 3261.
  • 3261 Hi-Fatigue Evidence Summary Appendix 2 - Scheerlinck T, et al

    A PDF showing a report on Hi-Fatigue bone cement by Sheerlinck T, et al for ICN 3261.
  • 3261 Hi-Fatigue Evidence Summary Appendix 3 - Vaziri et al

    A PDF showing a report on Hi-Fatigue bone cement by Vaziri et al for ICN 3261.
  • 3261 Hi-Fatigue Evidence Appendix 4 - Proceedings of the International Consensus Meeting on Periprosthetic Joint Infection

    A PDF showing a report on periprosthetic joint infection for ICN 3261.
  • 3261 Heraeus Medical Demand Capture Form

    An Excel file containing a demand capture form for if a product required is Protect Demand Managed and not been ordered previously.
  • 3261 Heraeus Medical Demand Management Escalation Form

    A Word file containing an Escalation Form to be completed when either additional one-off product or a review of daily threshold allocation is required.
  • 3261 Heraeus Medical Supply Distribution Bone Cement Customer Briefing

    A PDF showing the customer briefing for ICN 3261.
    Login to view the downloads
  • 3261 Heraeus Zimmer Biomet Hi-Fatigue G Bone Cement Mixing Guidance

    A PDF showing mixing guidance for Zimmer Biomet Hi-Fatigue G Bone Cement for ICN 3261.