Guardian Distal Femur Axial Pin
This recall has been terminated (originally issued August 24, 2004).
- Company
- Wright Medical Technology Inc
- Recall Initiated
- July 14, 2004
- Posted
- August 24, 2004
- Terminated
- July 5, 2005
- Recall Number
- Z-1405-04
- Quantity
- 44
- Firm Location
- Arlington, TN
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for self -locking axial pin to dislodge and 'back out'.
Distribution
Nationwide. Ontario, and Taiwan, ROC
Lot / Code Info
Part No. 25002111, Serial No. 02217952 Part No. 25002112, Serial No. 01214391 Part No. 25002112, Serial No. 01215073 Part No. 25002113, Serial No. 01214533 Part No. 25002114, Serial No. 01215034 Part No. 25002114, Serial No. 01215074
Root Cause
Other
Action Taken
The firm sent out product correction notifications to implanting surgeons by letter dated 07/14/2004 to notify the surgeons of the dislodgement issue.
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