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| Issued: 16 January 2008 at 15:30 |
Ref: MDA/2008/003
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Immediate action |
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Action |
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Update |
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Information request |
This alert updates MDA/2007/092 issued on 04 December 2007.
| Device: Total knee replacement implants. VKS, RT-Plus and TC-Plus femoral and tibial knee components manufactured by Plus Orthopaedics/Smith & Nephew Orthopaedics Ltd (specific lot numbers). |
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| Problem: Extension of recall of implants which may have incorrect alloy composition. |
>Page 2 |
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Action by:
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Action:
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Distributed to:
* via CE Bulletin |
>Page 2 |
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| 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 |
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| Appendix: Manufacturer’s extended list of affected products distributed to UK hospitals (in pdf only). |
>Page 4-7 |
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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 30 January 2008
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Deadline (action complete): 17 March 2008
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