TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Right, REF 71701125R. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot.
This recall has been terminated (originally issued September 16, 2008).
- Company
- Smith & Nephew Inc
- Recall Initiated
- April 22, 2008
- Posted
- September 16, 2008
- Terminated
- May 28, 2010
- Recall Number
- Z-2088-2008
- Quantity
- 16
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory.
Distribution
Nationwide and Australia, Belgium, Canada, Denmark, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Sweden, and United Kingdom.
Lot / Code Info
Lot Nos.: 07EM17278, exp. 05/2017; 07DM21938, exp. 04/2017
Root Cause
Process control
Action Taken
All affected Smith & Nephew Sales Representatives were notified of problem and the recall via certified letter and e-mail on 4-22-08. All affected Smith & Nephew International Distributors were notified via email on 4-22-08 and 4-23-08. They were instructed to immediately notify their accounts concerning the recall. If you have questions, contact Customer Service at 800-238-7538.