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U.S. Department of Health and Human Services

Class 2 Device Recall TRIGEN INTERTAN Nail

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  Class 2 Device Recall TRIGEN INTERTAN Nail see related information
Date Initiated by Firm April 04, 2014
Date Posted May 20, 2014
Recall Status1 Open3, Classified
Recall Number Z-1637-2014
Recall Event ID 68043
510(K)Number K040212  
Product Classification Nail, fixation, bone - Product Code JDS
(1) REF 71676515, 10 MM X 10 CM, 125 degree, LEFT,
(2) REF 71676556, 11.5 MM X 36 CM, 125 degree, RIGHT,
(3) REF 71676558, 11.5 MM X 38 CM, 125 degree, RIGHT,
(4) REF 71676561, 11.5 MM X 42 CM, 125 degree, LEFT,
Smith & Nephew, Inc. Orthopedic fixation device.
Code Information (1) REF 71676515, Lot Number 13LT36602

(2) REF 71676556, Lot Numbers: 13LT36604, 13MT37354, 13MT37947, 14AT38705, 14AT38714

(3) REF 71676558, Lot Numbers: 13KT36282, 13MT37356, 13MT37664, 13MT37949, 14AT38187

(4) REF 71676561, Lot Numbers: 13LT36605, 13MT37358, 14AT38188
Recalling Firm/
Smith & Nephew Inc
1450 E. Brooks Rd
Memphis TN 38116
For Additional Information Contact Joe Metzger
Manufacturer Reason
for Recall
A manufacturing error resulted in the set screw being inserted too deep in the affected nails.
FDA Determined
Cause 2
Process control
Action The firm initiated the recall via an "Urgent - Product Recall 1st Notification - Urgent" letter and e-mail on 04/04/2014, identifying the product, explaining the problem, and the potential risk associated with using the product. Customers are to inspect their inventory, and locate and quarantine any affected product. Additionally, the Inventory Return Certification form should be completed and returned along with any affected product identified, once a Return Authorization number has been obtained from Smith & Nephew's Safety Affairs Department.
Quantity in Commerce 1,253 units total
Distribution Worldwide Distribution -- USA, France, Germany, Sweden, Switzerland, UK, Canada, Australia, Japan, China, India, Dubai, South Africa, South Korea, Mexico, and Venezuela.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JDS and Original Applicant = SMITH & NEPHEW, INC.