- Be aware of the manufacturer’s Field Safety Notice
- Locate and quarantine all batches immediately
- Return quarantined product to the manufacturer
- Complete the return slip as requested by the manufacturer
- Contact the manufacturer to arrange for an alternative device
All those who use these devices.
Deadlines for actions
Actions underway: 3 March 2017
Actions complete: 31 March 2017
Smith & Nephew
Tel: 01480 423 200
If you are responsible for cascading these alerts in your organisation, these are our suggested distribution lists.
Trusts (NHS boards in Scotland)
CAS and SABS (NI) liaison officers for onward distribution to all relevant staff including:
- A&E departments
- Biomedical engineering staff
- Day surgery units
- General surgeons
- General surgery
- General surgical units, directors of
- Health and safety managers
- Orthopaedic surgeons
- Purchasing managers
- Risk managers
- Supplies managers
- Theatre managers
- Theatre nurses
Public Health England
Directors for onward distribution
Establishments registered with the Care Quality Commission (CQC) (England only):
- Hospitals in the independent sector
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/2017/002 or 2016/011/018/701/004.
Mariam Ali or Sara Vincent, MHRA
Tel: Tel: 020 3080 6877 / 020 3080 7169
Email: email@example.com or firstname.lastname@example.org
MHRA Devices Clinical Team
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,
Department of Health,
Social Services and Public Safety
Tel: 028 9052 3868
Reporting adverse incidents in Northern Ireland
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)