Odyssey Femoral Holder/Driver, Part Number K001-7410, Non-sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline
FDA device recall Z-0290-2008 · posted 2007-11-27 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology Inc
- Reason for recall
- Breakage: breaking of the connecting foot that is on the distal surface of the instrument
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HWR
- Quantity affected
- 66 units
- Distribution
- Worldwide-USA and Australia
- Date initiated
- 2007-10-04
- Date posted
- 2007-11-27
- Date terminated
- 2009-07-22
- Location
- Arlington, TN
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