Recall Z-0179-2007 ยท KFK Saw, Pneumatically Powered
Linvatec Corp.
ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 5059-09: Used on ConMed Linvatec Sternum Saw Handpieces (ConMed Linvatec, Hall. Versipower, Versipower Plus Handpieces) and sold individually.
| Date | Nov 16, 2006 (initiated Dec 20, 2005) |
| Status | Terminated |
| Reason | The Sternum Saw Collet Nut that is used to insert and hold the saw blade in place may not always allow for the easy insertion of a saw blade into the handpiece for use. The nut needs to be in a certain position in order for the blade to be inserted and this may delay the operation of the device especially in emergency situations. |
| Root cause | Other |
| Action | Linvatec will send each consignee a recall package that will include: a 12/20/2005 recall letter and reply form, A product correction instruction sheet , a new Sternum Saw Collet Nut and an assembly manual. Linvatec will also contact each consignee by phone or email. All consignees that have not responded by 30 days after the first mailing will be re-contacted by the firm by mail, phone or email. |
| Quantity | 11424 units |
| Distribution | Worldwide, including USA, Mexico, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.