Class 2 Device Recall TRIGEN INTERTAN 10S

• Date Initiated by Firm: October 24, 2017
• Create Date: November 16, 2017
• Recall Status: Open, Classified
• Recall Number: Z-0097-2018
• Recall Event ID: 78390
• 510(K)Number: K040212
• Product Classification: Nail, fixation, bone - Product Code JDS
• Product: smith&nephew TRIGEN INTERTAN 10S, REF 71675384, 10 MM X 18 CM NAIL, 130o (degrees), SET SCREW PREASSEMBLED IN NAIL
• Code Information: Lot number 16LM07111
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc.; 1450 E Brooks Rd; Memphis TN 38116-1804
• For Additional Information Contact: David Snyder; 978-749-1440
• Manufacturer Reason for Recall: A single lot of INTERTAN 10S 10 MM X 18 CM 130 D was manufactured with the screw inserted upside down.
• FDA Determined Cause: Employee error
• Action: Smith & Nephew sent an Urgent Medical Device Recall Notice dated October 24, 2017, to all affected customers. The firm requested return of the product. Please follow the instructions on the attached Response Form. For further questions, please call (978) 749-1440.
• Quantity in Commerce: 17 units
• Distribution: US Distribution - TN, IL, CT, MO, CA., and Internationally to Italy and Germany
• 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