FDA Device

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

Hazard

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

What You Should Do

Remedy

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.

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Products

Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002
Brand
Wright Medical Technology Inc
UPC
Lot Numbers: 047367193, 067380510, and 077414021

Units Affected

66 units

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