Z-2085-2008

TRIGEN Hind Foot Fusion Nail, 10mm X 20mm Left, REF 71701020L. The device is indicated for degeneration...

Name: Z-2085-2008 TRIGEN Hind Foot Fusion Nail, 10mm X 20mm Left, REF 71701020L. The device is indicated for degeneration...
Creator: Smith & Nephew Inc
Published: 2008-04-22
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2008-04-22 / Terminated / root cause: manufacturing process

FDA source

Smith & Nephew Inc began a recall of TRIGEN Hind Foot Fusion Nail, 10mm X 20mm Left, REF 71701020L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and... on 2008-04-22. The reason FDA records is "One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2085-2008
Status: Terminated
Initiated: 2008-04-22
Posted: 2008-09-16
Terminated: 2010-05-28
Recalling firm: Smith & Nephew, Inc.
Product: TRIGEN Hind Foot Fusion Nail, 10mm X 20mm Left, REF 71701020L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot.
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory.
Root cause tag: manufacturing process
FDA 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 in commerce: 8
Distribution: Nationwide and Australia, Belgium, Canada, Denmark, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Sweden, and United Kingdom.
Product codes and lots: Lot No. 07EM23985, exp. 05/2017

Product code HSB

K043052Class IITrigen Hindfoot Fusion NailSmith & Nephew, Inc. / cleared 2004-11-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)