Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002
This recall has been terminated (originally issued November 27, 2007).
- Company
- Wright Medical Technology Inc
- Recall Initiated
- October 4, 2007
- Posted
- November 27, 2007
- Terminated
- July 22, 2009
- Recall Number
- Z-0290-2008
- Quantity
- 66 units
- Firm Location
- Arlington, TN
- Official Source
- View on FDA website ↗
Reason for Recall
Breakage: breaking of the connecting foot that is on the distal surface of the instrument
Distribution
Worldwide-USA and Australia
Lot / Code Info
Lot Numbers: 047367193, 067380510, and 077414021
Root Cause
Device Design
Action Taken
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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