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Class 2 Device Recall TRIGEN Hind Foot Fusion Nail |
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Date Initiated by Firm |
April 22, 2008 |
Date Posted |
September 16, 2008 |
Recall Status1 |
Terminated 3 on May 28, 2010 |
Recall Number |
Z-2086-2008 |
Recall Event ID |
48429 |
510(K)Number |
K043052
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Product Classification |
Intramedullary fixation rod and accessories - Product Code HSB
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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. |
Code Information |
Lot Nos.: 07FM05443, exp. 06/2017; 07FM05447, exp. 06/2017; 07FM05444, exp. 06/2017; 07FM05445, exp. 06/2017; 07FM05446, exp. 06/2017 |
Recalling Firm/ Manufacturer |
Smith & Nephew Inc 1450 E Brooks Rd Memphis TN 38116-1804
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For Additional Information Contact |
Victor Rocha 901-399-6771
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Manufacturer Reason for Recall |
One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory.
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FDA Determined Cause 2 |
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 |
40 |
Distribution |
Nationwide and Australia, Belgium, Canada, Denmark, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Sweden, and United Kingdom. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = HSB and Original Applicant = SMITH & NEPHEW, INC.
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