Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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 Recall Z-2086-2008 · Posted 2008-09-16

Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeHSB
Date Initiated2008-04-22
Date Terminated2010-05-28
Product Quantity40

Reason for Recall

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

Firm 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.

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043052TRIGEN HINDFOOT FUSION NAILSmith & Nephew, Inc. · 2004-11-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑