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U.S. Department of Health and Human Services

Class 2 Device Recall Collagen Matrix Inc.

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  Class 2 Device Recall Collagen Matrix Inc. see related information
Date Initiated by Firm August 25, 2015
Create Date March 11, 2016
Recall Status1 Terminated 3 on May 11, 2016
Recall Number Z-1096-2016
Recall Event ID 73222
510(K)Number K043034  
Product Classification Bone grafting material, animal source - Product Code NPM
Product NuOSS Cancellous

Intended for use in dental surgery.
Code Information Reference No. BM2C20010-U Lot no. BM2CU15E2 
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		 On 8/25/2015, Collagen Matrix, Inc discovered that one of the 171 units of NuOss Cancellous product shipped to a distributor may have included an incorrect size.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action Collagen Matrix Inc. notified their sole customer on November 17, 2015. On August 25, 2015, during a review of inventory, tt was discovered that of the 171 units product shipped, 19 units may have been the incorrect size. For further questions please call (201) 405-1477
Quantity in Commerce 171 units
Distribution US Distribution to the state of : MA
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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