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FDA Medical Device Recalls (openFDA)

Wright Medical Technology Inc: Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002

Recall number
Z-0290-2008
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
Status
Terminated
Initiated
2007-10-04
Posted
2007-11-27
Terminated
2009-07-22
Reason
Breakage: breaking of the connecting foot that is on the distal surface of the instrument
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
66 units
Distribution
Worldwide-USA and Australia
Lot, serial or model codes
Lot Numbers: 047367193, 067380510, and 077414021
510(k) numbers
not on file
PMA numbers
not on file
Product code
HWR
Firm FEI
1043534
Firm city
Arlington
Firm state
TN
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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