Z-0179-2007

ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 5059-09: Used on ConMed Linvatec Sternum Saw...

Name: Z-0179-2007 ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 5059-09: Used on ConMed Linvatec Sternum Saw...
Creator: Linvatec Corp.
Published: 2005-12-20
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2005-12-20 / Terminated

FDA source

Linvatec Corp. began a recall of ConMed Linvatec Sternum Saw Collet Nut, Catalog Number 5059-09: Used on ConMed Linvatec Sternum Saw Handpieces (ConMed Linvatec, Hall. Versipower, Versipower... on 2005-12-20. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0179-2007
Status: Terminated
Initiated: 2005-12-20
Posted: 2006-11-16
Terminated: 2012-07-11
Recalling firm: Linvatec Corporation
Product: 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.
Product code: KFK Saw, Pneumatically Powered
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.
FDA 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 in commerce: 11424 units
Distribution: Worldwide, including USA, Mexico, and Canada.
Product codes and lots: All serial numbers are being recalled.

Product code KFK

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)