Class 3 Device Recall Integra LifeSciences Corp.

• Date Initiated by Firm: January 25, 2017
• Create Date: March 04, 2017
• Recall Status: Terminated on November 08, 2017
• Recall Number: Z-1410-2017
• Recall Event ID: 76408
• 510(K)Number: K011716
• Product Classification: Staple, fixation, bone - Product Code JDR
• Product: The UNI-CP System; Model Number: 330230SND.
• Code Information: Lot # FEDT
• FEI Number: 3003418325
• Recalling Firm/ Manufacturer: Integra LifeSciences Corp.; 311 Enterprise Dr; Plainsboro NJ 08536-3344
• For Additional Information Contact: 609-275-0500
• Manufacturer Reason for Recall: The firm received one complaint from one non-US sales representative (France) that the label on the UNI-CP plate was incorrect.
• FDA Determined Cause: Device Design
• Action: Integra LifeSciences Corp. issued a recall letter/return response form on 1/25/2017.
• Quantity in Commerce: 39 units
• Distribution: Nationwide
• 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 = JDR