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| Issued: 04 October 2007 at 14:00 |
Ref: MDA/2007/076
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Immediate action |
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Action |
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Update |
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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 |
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| 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. |
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Action by:
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Action:
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>Page 2 |
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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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Action deadlines for the Safety Alert Broadcast System (SABS)
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Deadline (action underway): 18 October 2007
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Deadline (action complete): 04 December 2007
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MDA/2007/076 - Bioresorbable screw: CALAXO interference screw implants manufactured by Smith & Nephew Inc 
