Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Neomem

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Neomemsee related information
Date Initiated by FirmMarch 19, 2019
Create DateMay 22, 2019
Recall Status1 Terminated 3 on May 12, 2020
Recall NumberZ-1389-2019
Recall Event ID 82638
510(K)NumberK011695 K003339 
Product Classification Barrier, animal source, intraoral - Product Code NPL
ProductNeomem 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
FEI Number 3003300673
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
ActionCitagenix 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 Commerce45 units -US;170 units OUS
DistributionWorldwide distribution - US nationwide in the states of CA, FL and countries of Canada, Israel.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NPL
-
-