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U.S. Department of Health and Human Services

Class 2 Device Recall Integra Mosaik Putty

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  Class 2 Device Recall Integra Mosaik Putty see related information
Date Initiated by Firm January 16, 2009
Date Posting Updated March 06, 2009
Recall Status1 Terminated 3 on June 25, 2009
Recall Number Z-1034-2009
Recall Event ID 50899
510(K)Number K062353  
Product Classification Calcium Bone Void Filler Compound - Product Code MQV
Product Integra Mosaik Putty, 15cc, Catalog # PTY10256
Integra Lifesciences, Plainsboro, NJ
Code Information Lot codes: 105B00135019, 105B00135020, 105B00135021, and 105B00135022.
Recalling Firm/
Manufacturer
Integra LifeSciences Corp
105 Morgan Ln
Plainsboro NJ 08536-3339
For Additional Information Contact Juith O'Grady
609-936-2375
Manufacturer Reason
for Recall
Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.
FDA Determined
Cause 2
Pending
Action Urgent: Product Recall Notification letters were sent on January 21, 1009 via Federal Express. The letter asked customers to immediately quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and arrangement of product returns. The enclosed "Recall Acknowledgement and Return Form" indicating whether or not customers possess any of the affected product should also be completed and returned. Company is conducting recall to the hospital level. Questions should be directed to Judy O'Grady at 609-936-2317.
Quantity in Commerce 88 units
Distribution Nationwide Distribution -- including states of FL, CA, GA, FL, CT, MT, IL, TX, WA, TN, NC, IN, AZ, MD, CO, MO, and TN.
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 = MQV and Original Applicant = INTEGRA LIFESCIENCES CORPORATION
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