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U.S. Department of Health and Human Services

Class 2 Device Recall Total Contact Cast System

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  Class 2 Device Recall Total Contact Cast System see related information
Date Initiated by Firm August 18, 2017
Create Date April 24, 2018
Recall Status1 Terminated 3 on July 19, 2018
Recall Number Z-1487-2018
Recall Event ID 79636
Product Classification Bandage, cast - Product Code ITG
Product TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
Code Information Lot 1216033
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Dr. Patricia Kihn
713-309-3966
Manufacturer Reason
for Recall		 A quarantined lot of the devices was released for sale. Devices from this lot may experience increased exothermic reaction causing higher levels of heat output which exceed the product specifications.
FDA Determined
Cause 2		 Process control
Action On 8/18/17, the recalling firm's sales reps notified affected consignees of the recall and distributed customer letters. Customers were asked to examine their inventory for product from the affected lot, warned not to use the product, complete the included "Acknowledgement and Return Form", and return the form by email or fax. Customers were provided with a Customer Service number: 1-800-654-2873.
Quantity in Commerce 250
Distribution US nationwide distribution.
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.
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