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TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Left, REF… recallZ-2083-2008 · Smith & Nephew Inc · initiated Apr 22, 2008

Terminated All recalls posted in September 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smith & Nephew Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-2083-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 22, 2008
Posted by the FDA
Sep 16, 2008
Recalling firm
Smith & Nephew Inc
Quantity
34
Product code
HSB
FDA submissions
K043052
Distribution
Nationwide and Australia, Belgium, Canada, Denmark, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Sweden, and United Kingdom.

Product description

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.

Code information (models, lots, serial numbers)

Lot Nos.: 07GM00339, exp. 07/2017; 07EM23987, exp. 05/2017; 07EM23988, exp. 05/2017; 07EM23990, exp. 05/2017; 07EM23989, exp. 05/2017

Other devices under the same FDA submission

11 devices cleared under K043052 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 48429).

Sources and updates

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