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U.S. Department of Health and Human Services

Class 2 Device Recall Integra External Fixation System Rocker Bottom Model 12225400

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  Class 2 Device Recall Integra External Fixation System Rocker Bottom Model 12225400 see related information
Date Initiated by Firm July 01, 2016
Create Date July 27, 2016
Recall Status1 Terminated 3 on December 16, 2016
Recall Number Z-2296-2016
Recall Event ID 74583
510(K)Number K140463  
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
Product Integra External Fixation System Rocker Bottom Model # 12225400.

For use in the treatment of bone conditions amenable to treatment by the use of external fixation.
Code Information Lot # PN625.
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Dr. Patricia Kihn
717-840-3431
Manufacturer Reason
for Recall		 The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
FDA Determined
Cause 2		 Device Design
Action All affected consignees were notified via an "Urgent: Voluntary Medical Device Recall" letter sent on 7/1/16. The letter identified the affected product as well as the reason for the recall. Customers were asked to check their traceability records for shipments of the affected product. If the affected parts are found, customers are to stop use and distribution. A copy of the letter should be provided to any customers that the product may have been distributed to. The attached "Acknowledgement and Return Form" should be completed and returned regardless if customers have affected product or not. Questions regarding the instructions should be directed to Customer Service at 1-800-654-2873.
Quantity in Commerce 27 units
Distribution Distributed in the US to the states of FL, VA, OK, CO, DC, and IN.
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 = KTT and Original Applicant = ASCENSION ORTHOPEDIC
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