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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 June 12, 2012
Recall Status1 Terminated on February 14, 2013
Recall Number Z-1795-2012
Recall Event ID 61717
Premarket Notification
510(K) Number
K063124 
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
Product Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine. and pelvis not intrinsic to the stability of the bony structure. Integra Mozaik is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bone void or a defect Integra Mozaik is reabsorbed and replaced with bone during the healing process.
Code Information Strip Part Number 7701513001 510 K- K063124 Device Listing Number - D001098 Integra MOZAIKTM Strip IOcc Reference number - CCM I021OITL Batch Number - 105BR0215955 Integra MOZAIKTM Strip 10cc Reference Number - CCM I021OITL Batch Number - 105BR0216149
Recalling Firm/
Manufacturer
Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro, New Jersey 08536-3344
For Additional Information Contact Mr. David Gronostajski
609-936-6822
Manufacturer Reason
for Recall
The Instructions for Use {IFU} {Putty Part Number 7700713001 and Strip Part Number 770151300l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term "bone marrow aspirate". The term is incorrectly translated in Spanish and French,
FDA Determined
Cause 2
TRAINING: Employee Error
Action Integra LifeSciences sent a Field Safety Notice letter dated October 11, 2011 to their sole foreign consignee. The letter identified the affected products, problem and actions to be taken. The consignee was asked to remove the existing Instructions for Use (IFU) and replace it with the corrected IFU. The consignee was instructed to complete and return the attached Distributor Rework and Acknowledgment Forms provided with the customer notification letter as documentation that instructions were followed and all required actions were completed. For any questions, call: +33 (0)4 37 47 5900 , fax: +33 (0)4 37 47 5999; or email: carole.robin@integralife.com.
Quantity in Commerce 22 units
Distribution Worldwide Distribution
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 CORP.
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