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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-2085-2008
Recall Event ID 48429
510(K)Number K043052  
Product Classification Intramedullary fixation rod and accessories - Product Code HSB
Product TRIGEN Hind Foot Fusion Nail, 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.
Code Information Lot No. 07EM23985, exp. 05/2017
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 8
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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