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U.S. Department of Health and Human Services

Class 2 Device Recall Integra

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 Class 2 Recall
Integra
see related information
Date Posted February 08, 2012
Recall Status1 Terminated on May 21, 2013
Recall Number Z-0986-2012
Recall Event ID 60938
Premarket Notification
510(K) Number
K062353 
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
Product Integra OS Osteoconductive Scaffold Putty (2.5 cc and 5 cc). Integra OS Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal system. Following placement in the bony void or gap (defect), Integra OS Putty is resorbed and replaced with bone during the healing process.
Code Information 2.5 cc Part numbers - IOS10125 Lot numbers - N199416 and 215944 5 cc Part numbers - lOS10155 Lot numbers - 208500, 206504 and N216026
Recalling Firm/
Manufacturer
Integra LifeSciences Corp
105 Morgan Ln
Plainsboro, New Jersey 08536-3339
For Additional Information Contact Mr. Srinivas Balusu
609-936-2464
Manufacturer Reason
for Recall
Integra OS Osteoconductive Putty is labeled with incorrect storage conditions.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action Integra issued an "Urgent: Product Recall Notification" to customers and sales specialists on 10/7/2011. They were advised of the problem and provided instructions on how to handle the affected product.
Quantity in Commerce 45 units
Distribution Nationwide Distribution - Including the states of CA, OK, MD and VA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQV and Original Applicant = INTEGRA LIFESCIENCES CORPORATION
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