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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

  • In February 2026 Heraeus Medical encountered a packaging fault which temporarily stopped production of their pouch bone cement products.
  • The company has confirmed it has now fully resumed production at their main site after resolving the technical machine failure.
  • Due to required production cycles and sterilisation times, the first products are expected to be released to the global market from the end of June 2026. It is expected to be July or August before all product variants are available and the backlog cleared, enabling a full return to business as usual.
  • We have an incident team managing the incident, working closely with Heraeus Medical.
  • NHS Supply Chain has two clinically assured suitable alternatives available 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.
  • 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.

Next steps:

  • Trusts should continue to order the alternative Zimmer Biomet High Fatigue G or Johnson & Johnson CMW Smartset GHV Gentamicin products until Haraeus products become available in sufficient quantities.
  • Continue to check this ICN for updates on when Haraeus products will be available to order.
  • See our Downloads ▼ section  to read a customer briefing which sets out the alternative 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.
  • 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:

  • Temporary switch required on Zimmer Biomet High Fatigue G.
  • One product code is temporarily unavailable to order due to a supplier shortage:
    • FQT85055 – Antibiotic Hi-Fatigue G Bone Cmt 1×40 packs.
  • Trusts should switch to product code:
    •  FQT85054 – Antibiotic Hi-Fatigue G Bone Cmt 2×40 packs.
  • There is good availability of FQT85054 although it remains subject to Protect Demand Management to ensure fair supply of available stock across the NHS.

Next steps:

  • Trusts should continue to order the alternative Zimmer Biomet High Fatigue G Bone Cmt 2×40 packs instead.
  • Continue to check this ICN for updates on Heraeus products.

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 Customer Letter Production Restart 29 April 2026

    A PDF showing the customer letter regarding production restart for ICN 3261.
  • 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.