Z-0290-2008

Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc...

Name: Z-0290-2008 Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc...
Creator: Wright Medical Technology Inc
Published: 2007-10-04
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2007-10-04 / Terminated / root cause: design

FDA source

Wright Medical Technology Inc began a recall of Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002 on 2007-10-04. The reason FDA records is "Breakage: breaking of the connecting foot that is on the distal surface of the instrument". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0290-2008
Status: Terminated
Initiated: 2007-10-04
Posted: 2007-11-27
Terminated: 2009-07-22
Recalling firm: Wright Medical Technology Inc
Product: Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002
Product code: HWR Driver, Prosthesis
Reason for recall: Breakage: breaking of the connecting foot that is on the distal surface of the instrument
Root cause tag: design
FDA root cause: Device Design
Action: The firm notified their distributors of the recall on October 4, 2007, with an Urgent Medical Device Recall letter explaining the problem and requesting return of the product from their inventory and from their consignees. The hospitals were notified of the recall on October 4, 2007 using the same Urgent Device Recall Letter.
Quantity in commerce: 66 units
Distribution: Worldwide-USA and Australia
Product codes and lots: Lot Numbers: 047367193, 067380510, and 077414021

Product code HWR

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)