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MDA/2007/068 - Hip implants for hemiarthroplasty - Austin-Moore, F.R. Thompson and Thompson Modular endoprostheses manufactured by Biomet

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/068
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 8
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 5 September 2007 at 10:30
Ref: MDA/2007/068


Tick mark
Immediate action
 
Action
 
Update
 
Information request


Device:
Hip implants for hemiarthroplasty – Austin-Moore, F.R. Thompson and Thompson Modular endoprostheses manufactured by Biomet UK Ltd.

 >Page 2

Problem:
Recall due to potential failure of sterile barrier packaging which could compromise product sterility.

 >Page 2

Action by:

  • Orthopaedic surgeons
  • Supplies managers
  • Theatre managers
  

Action:

  • Identify and quarantine any unimplanted affected devices.
  • Do not implant affected devices.
  • Return affected devices to the manufacturer.
  

Distributed to:

NHS trusts in England - Chief Executives*
Healthcare Commission (CHAI) - Headquarters
Primary care trusts in England - Chief Executives*

* via CE Bulletin

 >Page 2

Contacts:
Details of manufacturer contacts and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.

>Pages 2-3

Appendix:
Manufacturer’s recall letter and list of catalogue numbers (in pdf only).

>Pages 4-8



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 12 September 2007
Deadline (action complete): 26 September 2007


Page last modified: 07 February 2008