—#71370

Product

TRIGEN Hind Foot Fusion Nail, 10mm X 16mm Left, REF 71701016L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot.

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K043052
Affected lot / code info: Lot Nos.: 07FM05443, exp. 06/2017; 07FM05447, exp. 06/2017; 07FM05444, exp. 06/2017; 07FM05445, exp. 06/2017; 07FM05446, exp. 06/2017

Why it was recalled

One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew Inc
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: Nationwide and Australia, Belgium, Canada, Denmark, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Sweden, and United Kingdom.

Timeline

Recall initiated: 2008-04-22
Posted by FDA: 2008-09-16
Terminated: 2010-05-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71370. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.