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MDA/2009/016 - Total knee replacement implant femoral components – PFC SIGMA. Manufactured by DePuy International Limited

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Document details:

Type: Medical Device Alert
Series No: MDA/2009/016
Audience: Healthcare professionals
Published: 24 February 2009
Format: Electronic and paper
Size: A4
Pages: 4
Price: free
ISBN/ISSN:
Author:
Copyright: Crown
   

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Page 1

Issued: 24 February 2009 at 14:30
Ref: MDA/2009/016
 
Immediate action
 
Immediate action update
Tick mark
Action
 
Action update


Device:
Total knee replacement implant femoral components – PFC SIGMA. Manufactured by DePuy International Limited.

MDA/2009/016 - Product Label
Problem:
Potential for implanting incorrect anatomical components due to unclear labelling.

Action:

  • Check inner and outer packaging label carefully to ensure you have the correct anatomical component for the correct side before use.
  • Contact the manufacturer if you are not certain about the meaning of symbols used on the label.
Action by:
Orthopaedic surgeons
Orthopaedic theatre nurses
Theatre managers

Contact:

Manufacturer
Paul Arnott
Complaints & Vigilance Manager
DePuy International Limited

Tel: 0113 387 6298 

E-mail: parnott@dpygb.jnj.com


Action deadlines for the Central Alerting System (CAS)
Deadline (action underway): 10 March 2009
Deadline (action complete): 24 March 2009


Page last modified: 24 February 2009