Recall Z-2083-2008 ยท HSB Rod, Fixation, Intramedullary And Accessories
Smith & Nephew Inc
TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Left, REF 71701125L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot.
| Date | Sep 16, 2008 (initiated Apr 22, 2008) |
| Status | Terminated |
| Reason | One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 34 |
| Distribution | Nationwide and Australia, Belgium, Canada, Denmark, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Sweden, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043052 | TRIGEN HINDFOOT FUSION NAIL Smith & Nephew, Inc., Nov 24, 2004 |