Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
Page 1
| Issued: 5 September 2007 at 10:30 |
Ref: MDA/2007/068
|
|
Immediate action |
|
|
Action |
|
|
Update |
|
|
Information request |
| Device: Hip implants for hemiarthroplasty – Austin-Moore, F.R. Thompson and Thompson Modular endoprostheses manufactured by Biomet UK Ltd. |
>Page 2 |
||||||
| Problem: Recall due to potential failure of sterile barrier packaging which could compromise product sterility. |
>Page 2 |
||||||
|
Action by:
|
|||||||
|
Action:
|
|||||||
|
Distributed to:
* 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 |
||||||
| Appendix: Manufacturer’s recall letter and list of catalogue numbers (in pdf only). |
>Pages 4-8 |
|
Action deadlines for the Safety Alert Broadcast System (SABS)
|
|
|
Deadline (action underway): 12 September 2007
|
Deadline (action complete): 26 September 2007
|

