My HPRA: Register

Shelhigh Implantable Devices

Notice type: Recall

Date: 10/05/2007

  

Product name or type:
Shelhigh Implantable Devices

Reference:
SN2007(01)

Manufacturer Or Supplier:
Shelhigh Incorporated, New Jersey, USA 
UK Medical Limited, Sheffield, United Kingdom (Distributor) 
Krijnen Medical, The Netherlands (Authorised Representative)

Target Audience:
Hospital Chief Executive Officers; Hospital Risk Managers; Cardiothoracic Surgeons; Cardiologists Vascular Surgeons; Neurosurgeons; Gastrointestinal Surgeons; Urological Surgeons; Gynaecological Surgeons; General Surgeons

Problem Or Issue:
The Food & Drug Administration (FDA) issued a formal written request to Shelhigh Inc. to recall all its medical devices.

Background Information Or Related Documents:
On 17th April 2007, US Marshalls at the request of the FDA ordered the seizure of all implantable medical devices manufactured by Shelhigh Inc. as they had determined that significant deficiencies in Shelhigh''s manufacturing procedures exist.  The FDA indicated that these deficiencies may compromise the safety and effectiveness of the device, especially their sterility. 

On 2nd May 2007, the FDA issued a formal written request to Shelhigh Inc. to recall all its medical devices remaining in the market place, including end users and distribution outlets.   

Discussions are ongoing at a European level to determine any necessary action in the EU.    

The IMB has confirmed through communication with the manufacturer's United Kingdom distributor, UK Medical, that none of Shelhigh''s devices have been implanted in the Republic of Ireland since 2002.  However there is a possibility that patients may have had Shelhigh devices implanted abroad.

Shelhigh Implantable Devices Document

Actions To Be Taken:
Please ensure that all appropriate staff who are involved in the implantation / follow up of patients with this type of device are advised of the issue.   

The FDA press releases and further information are available on www.fda.gov.

Further Information:
All adverse incidents relating to a medical device should be reported to the:   

Health Products Regulatory Authority
Medical Devices Department 
Kevin O'Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2   

If you have any enquiries, you may contact the Medical Devices Department at:   
Telephone:        +353-1-6764971 
Fax:                  +353-1-6344033 
Email:               vigilance@imb.ie
Website:            www.hpra.ie

SN2007(01): Shelhigh Implantable Devices
SN2007(01): Shelhigh Implantable Devices - Attachment 1
SN2007(01): Shelhigh Implantable Devices - Attachment 2

« Back