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U.S. Department of Health and Human Services

Class 2 Device Recall TRIGEN (TM) LP SCREW, 4.5 MM X 37.5 MM

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  Class 2 Device Recall TRIGEN (TM) LP SCREW, 4.5 MM X 37.5 MM see related information
Date Initiated by Firm March 06, 2013
Date Posted April 17, 2013
Recall Status1 Open3, Classified
Recall Number Z-1132-2013
Recall Event ID 64669
510(K)Number K111025  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product TRIGEN (TM) L-P SCREW, 4.5 MM X 37.5 MM, TI-6AL-4V, QTY: (1), STERILE R, REF 71645437, Smith & Nephew, Inc. Memphis, TN 38116 USA

orthopedic surgery
Code Information Lot Number 12FM12182
Recalling Firm/
Smith & Nephew Inc
1450 E. Brooks Rd
Memphis TN 38116
For Additional Information Contact Joe Metzger
Manufacturer Reason
for Recall
One batch of 4.5 mm diameter Trigen Low-Profile Bone Screws were incorrectly anodized with a gold coating (indicating a 5 mm diameter) instead of a gray coating (indicating a 4.5 mm diameter).
FDA Determined
Cause 2
Process control
Action Smith & Nephew sent an Urgent Product Recall Notification letter dated March 6, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease use and distribution of the affected product and quarantine for return. Non-responding consignees were notified again on March 15, 2013, by email. Surgeons were to be notified by letter beginning on March 20, 2013. For questions regarding this recall call 978-749-1330.
Quantity in Commerce 23 units
Distribution Nationwide Distribution including CA, FL, GA, MA, MI, NC, SC, OH, and MO.
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 = HSB and Original Applicant = SMITH & NEPHEW, INC.