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U.S. Department of Health and Human Services

Class 2 Device Recall Neomem

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  Class 2 Device Recall Neomem see related information
Date Initiated by Firm March 19, 2019
Create Date May 22, 2019
Recall Status1 Terminated 3 on May 12, 2020
Recall Number Z-1389-2019
Recall Event ID 82638
510(K)Number K003339  K011695  
Product Classification Barrier, animal source, intraoral - Product Code NPL
Product Neomem Resorbable Collagen Membrane, 15 mm x 20 mm
Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material that is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery. Neomem¿ is also intended for use in patients with moderate to severe periodontal disease as a material for placement in periodontal defects to aid in wound healing of periodontal tissue.
Code Information Lot Number: OCF191255 UDI (01)00813954020884(17)211130(10)OCF191255
Recalling Firm/
Manufacturer		 Collagen Matrix, Inc.
110 Commerce Dr
Allendale NJ 07401-1622
For Additional Information Contact
201-405-1477
Manufacturer Reason
for Recall		 Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
FDA Determined
Cause 2		 Under Investigation by firm
Action Citagenix with the Manufacturer, Collagen Matrix, Inc. issued on, March 19, 2019, the Recall Notice via email advising of the problem, health risk, and action to take: determine the quantity on hand and quarantine. Check distribution records and determine whether any of the affected product was distributed to your customers. Complete the attached Acknowledgement of Receipt Form with the appropriate information and return within 72 hours of receiving this notice to initiate additional recall activities where applicable. Upon receipt of the completed form, Citagenix will provide a prepaid return shipping label with further instructions for returning product that remains in your possession and/or with additional recall activities. If you have any questions after reviewing this notice, please call 1-877-243-6724 between 8:00 am and 5:00 pm EST, Monday through Friday.
Quantity in Commerce 45 units -US;170 units OUS
Distribution Worldwide distribution - US nationwide in the states of CA, FL and countries of Canada, Israel.
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 = NPL and Original Applicant = COLLAGEN MATRIX, INC.
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