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MDA/2007/076 - Bioresorbable screw: CALAXO interference screw implants manufactured by Smith & Nephew Inc

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/076
Audience: Healthcare professionals
Published:
Format: Electronic and paper
Size: A4
Pages: 3
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 04 October 2007 at 14:00
Ref: MDA/2007/076

 

Tick mark
Immediate action
 
Action
 
Update
Tick mark
Information request


Device:
Bioresorbable screw: CALAXO interference screw implants manufactured by Smith & Nephew Inc.
All lot numbers and all item codes distributed since 2006.

>Page 2

Problem:
Recall due to pre-tibial soft tissue swelling after implantation of CALAXO screws leading to the need for surgical intervention to remove any remaining screw fragments.		  

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.

>Page 2

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



Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 18 October 2007
Deadline (action complete): 04 December 2007


Page last modified: 07 February 2008