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U.S. Department of Health and Human Services

Class 3 Device Recall Integra LifeSciences Corp.

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  Class 3 Device Recall Integra LifeSciences Corp. see related information
Date Initiated by Firm January 25, 2017
Create Date March 04, 2017
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = NEWDEAL S.A.
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