Recall Z-1389-2019 ยท NPL Barrier, Animal Source, Intraoral
Collagen Matrix, Inc.
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
| Date | Mar 19, 2019 |
| Status | Terminated |
| Reason | Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box |
| Root cause | 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 retu |
| Quantity | 45 units -US;170 units OUS |
| Distribution | Worldwide distribution - US nationwide in the states of CA, FL and countries of Canada, Israel. |
| FDA record | Open on fda.gov |