Smith & Nephew Inc TRIGEN Hind Foot Fusion Nail, 10mm X 25mm Left, REF 71701025L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
TRIGEN Hind Foot Fusion Nail, 10mm X 25mm Left, REF 71701025L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot.
Brand
Smith & Nephew Inc
Lot Codes / Batch Numbers
Lot No. 07FM16322, exp. 06/2017
Products Sold
Lot No. 07FM16322, exp. 06/2017
Smith & Nephew Inc is recalling TRIGEN Hind Foot Fusion Nail, 10mm X 25mm Left, REF 71701025L. The device is indicated for degenera due to One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026