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U.S. Department of Health and Human Services

Class 3 Device Recall RegenerOss Resorbable Xenograft, Porcine Anorganic Bone Mineral and ZCORE, Porcine Xenograft Part

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  Class 3 Device Recall RegenerOss Resorbable Xenograft, Porcine Anorganic Bone Mineral and ZCORE, Porcine Xenograft Part see related information
Date Initiated by Firm October 30, 2018
Create Date January 17, 2019
Recall Status1 Terminated 3 on May 12, 2020
Recall Number Z-0752-2019
Recall Event ID 81626
510(K)Number K140714  
Product Classification Bone grafting material, animal source - Product Code NPM
Product Porcine Anorganic Bone Mineral 4.0cc
Code Information UDI - (01)00813954022369(17)210430(10)PMCU18C4 Lot Number - PMCU18C4 Expiration Date - 04/30/2021 
Recalling Firm/
Manufacturer		 Collagen Matrix Inc
15 Thornton Rd
Oakland NJ 07436-3115
For Additional Information Contact Peggy Hansen
201-405-1477
Manufacturer Reason
for Recall		 There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled.
FDA Determined
Cause 2		 Employee error
Action On October 30, 2018 Collagen Matrix, notified their 2 distributors of the issue via email. The two distributors provided notices to their customers. Customers were advised to take the following actions: 1. If any of the items noted in the scope of the letter is held in stock, please return them along with a copy of the letter to the address provided. Replacement product will be provided upon receipt of the return. 2. Complete the Certificate of Acknowledgement within 15 days of receipt and email the completed form to the email address noted within your letter.
Quantity in Commerce 136 units
Distribution FL, 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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