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MDA/2007/084 - Spinal implants - locking nuts used in the Medtronic Colorado II spinal implant system

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/084
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: 5 November 2007 at 14:00
Ref: MDA/2007/083


 Tick mark
Immediate action
 
Action
 
Update
 Tick mark
Information request


Device:
Spinal implants - locking nuts used in the Medtronic Colorado II spinal implant system.

Catalogue number 8634111.
Lots: W07G2386, W07G2387, W07G2388, W07G2389, W07G2751, W07H0440, W07H1809 and W07H1810.

  
Problem:
Recall due to a manufacturing defect.

>Page 2

Action by:

  • Orthopaedic surgeons
  • Supplies managers
  • Theatre managers
  

Action:

  • Do not use affected devices.
  • Quarantine affected devices.
  • Return affected devices to the manufacturer.
  • Report all adverse incidents associated with this device to the manufacturer and the MHRA.

 

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): 16 November 2007
Deadline (action complete): 31 December 2007

 

Page last modified: 05 November 2007