ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 5059-09: Used on ConMed Linvatec Sternum Saw Handpieces (ConMed L
FDA device recall Z-0179-2007 · posted 2006-11-16 · Terminated
Recall details
- Recalling firm
- Linvatec Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KFK
- Quantity affected
- 11424 units
- Distribution
- Worldwide, including USA, Mexico, and Canada.
- Date initiated
- 2005-12-20
- Date posted
- 2006-11-16
- Date terminated
- 2012-07-11
- Location
- Largo, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.