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U.S. Department of Health and Human Services

Class 3 Device Recall ZCORE Syringe

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  Class 3 Device Recall ZCORE Syringe see related information
Date Initiated by Firm November 17, 2015
Create Date March 15, 2016
Recall Status1 Terminated 3 on May 10, 2018
Recall Number Z-1173-2016
Recall Event ID 73208
510(K)Number K140714  
Product Classification Bone grafting material, animal source - Product Code NPM
Product ZCORE Porcine Xenograft Particulate in Syringe

Product Intended for use in dental surgery such as:
-Augmentation or reconstructive treatment of alveolar ridge
-filling of defects after root resection, apicoectomy and cystectomy
-Filling of extraction sockets to enhance preservation of the alveolar ridge
-elevation of maxillary sinus floor
-Filling of periodontal defects in conjunction with products
-Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
-Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.
Code Information PMCS025   Lot No. PMCSU15A1  PMCS05  Lot No. PMCSU15A1   PMCS10  Lot No. PMCSU15A1  PMCS05  Lot No. PMCSU15A2    PMCS10 Lot No. PMCSU15A2  
Recalling Firm/
Manufacturer		 Collagen Matrix Inc
509 Commerce St
Franklin Lakes NJ 07417-1374
For Additional Information Contact Ms. Peggy Hansen
201-405-1477
Manufacturer Reason
for Recall		 The distributor, Osteogenics Biomedical, notified the firm that the syringes were not working properly and the syringes were being held in quarantine.
FDA Determined
Cause 2		 Component design/selection
Action Collagen Matrix Inc. notified their sole customer on 11/17/2015.
Quantity in Commerce 200 units
Distribution US in the state of TX
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 = NPM and Original Applicant = COLLAGEN MATRIX, INC.
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