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U.S. Department of Health and Human Services

Class 2 Device Recall TRIGEN Hind Foot Fusion Nail

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  Class 2 Device Recall TRIGEN Hind Foot Fusion Nail see related information
Date Initiated by Firm April 22, 2008
Date Posted September 16, 2008
Recall Status1 Terminated 3 on May 28, 2010
Recall Number Z-2088-2008
Recall Event ID 48429
510(K)Number K043052  
Product Classification Intramedullary fixation rod and accessories - Product Code HSB
Product TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Right, REF 71701125R. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and talocalcaneal articulations in the hindfoot.
Code Information Lot Nos.: 07EM17278, exp. 05/2017; 07DM21938, exp. 04/2017
Recalling Firm/
Manufacturer		 Smith & Nephew Inc
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact Victor Rocha
901-399-6771
Manufacturer Reason
for Recall		 One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory.
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 16
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
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.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = SMITH & NEPHEW, INC.
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