- Quarantine affected devices and obtain replacements from the manufacturer.
- Refer to the manufacturer’s Field Safety Notice (ref ZFA2017-332) for a full list of affected devices.
- Report all adverse events involving these devices to Zimmer Biomet and the MHRA or the appropriate Devolved Administration.
- Medical directors
- Orthopaedic departments
- Orthopaedic and trauma surgeons
- Decontamination and sterilisation departments
Deadlines for actions
Actions underway: 01 March 2018
Actions complete: 15 March 2018
Note: These deadlines are for users to have an action plan in place and not for the repairs to be complete.
Medical Device Safety Officers (in England): ask the manufacturer to add you to their distribution list for field safety notices (FSNs). This is to help with reconciliation.
Remember: if your organisation receives an FSN from a manufacturer, always act on it. Do not wait for a communication from MHRA.
The affected devices are being recalled by the manufacturer and replaced with alternative instruments which are already available and can be adequately cleaned using standard cleaning instructions.
This Medical Device Alert is being issued to ensure adequate awareness of the issue and appropriate action is taken.
Anne-Catherine Morancy Meister
Sulzer Allee 8
Tel: +41 58 854 82 37
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and NICAS liaison officers for onward distribution to all relevant staff including:
- Infection control & prevention directors
- Infection control departments
- Infection control nurses
- Operating department practitioners
- Operating theatres managers
- Orthopaedic surgeons
- Sterile services departments
Please note: CQC and OFSTED do not distribute these alerts. Independent healthcare providers and social care providers can sign up to receive MDAs directly from the Department of Health’s Central Alerting System (CAS) by sending an email to: firstname.lastname@example.org and requesting this facility.
Send enquiries about this notice to MHRA, quoting reference number MDA/2018/007 or 2017/010/003/701/010.
Jacques Pouget, MHRA
Tel: 020 3080 6143
Devices Clinical Team, MHRA
Tel: 020 3080 7274
Reporting adverse incidents in England
Through Yellow Card
Alerts in Northern Ireland are distributed via the NI SABS system.
Enquiries and adverse incident reports in Northern Ireland should be addressed to:
Northern Ireland Adverse Incident Centre, CMO Group,
Department of Health, Social Services and Public Safety
Tel: 028 9052 3868
Northern Ireland Adverse Incident Centre (NIAIC)
Please report directly to NIAIC using the forms on our website.
Enquiries and adverse incident reports in Scotland should be addressed to:
Incident Reporting and Investigation Centre,
Health Facilities Scotland,
NHS National Services Scotland
Tel: 0131 275 7575
Fax: 0131 314 0722
Reporting adverse incidents in Scotland
NHS Boards and Local Authorities in Scotland – report to Health Facilities Scotland.
Contractors such as private hospitals carrying out NHS work and private care homes that accept social work funded clients – report to Health Facilities Scotland.
Private facilities providing care to private clients report to the Care Inspectorate and MHRA.
Enquiries in Wales should be addressed to:
Healthcare Quality Division,
Tel: 02920 823 624 / 02920 825 510
Reporting adverse incidents in Wales
Report to MHRA through Yellow Card and follow specific advice for reporting in Wales in MDA/2004/054 (Wales).