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Terminated

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

FDA Recall Z-0290-2008 · Posted 2007-11-27

Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeHWR
Date Initiated2007-10-04
Date Terminated2009-07-22
Product Quantity66 units

Reason for Recall

Breakage: breaking of the connecting foot that is on the distal surface of the instrument

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide-USA and Australia

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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