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MDA/2007/081 - Orthopaedic bone cement restrictor instrumentation. DePuy SmartSeal™ pressurisers - femoral and acetabular pressurisers (5 pack) manufactured by DePuy CMW

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Document details:

Type: Medical Device Alert
Series No: MDA/2007/081
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: 25 October 2007 at 11:30
Ref: MDA/2007/081
 
Immediate action
 Tick mark
Action
 
Update
 
Information request


Device:
Orthopaedic bone cement restrictor instrumentation. DePuy SmartSeal™ pressurisers- femoral and acetabular pressurisers (5 pack) manufactured by DePuy CMW.

>Page 2 

Problem:
Recall of SmartSeal™ pressuriser as the outer pouch seal may be compromised.

>Page 2

Action by:

  • Orthopaedic surgeons
  • Supplies managers
  • Theatre managers.

 

Action:

  • Identify and quarantine affected devices.
  • Do not use affected devices.
  • Return affected devices to the manufacturer.

 

Distributed to:

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

>Page 3


Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 08 November 2007
Deadline (action complete): 21 December 2007


Page last modified: 25 October 2007