Z-1389-2019Class II

Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 -

Name: Z-1389-2019 Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 -
Creator: Collagen Matrix, Inc.
Published: 2019-03-19
License: https://open.fda.gov/license/

Collagen Matrix, Inc / initiated 2019-03-19 / Terminated / root cause: packaging

FDA source

Collagen Matrix, Inc. began a recall of Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioresorbable, implantable collagen material... on 2019-03-19. FDA classified it as Class II and gives the reason as "Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1389-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-19
Posted: 2019-05-22
Terminated: 2020-05-12
Recalling firm: Collagen Matrix, Inc
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.
Product code: NPL Barrier, Animal Source, Intraoral
Reason for recall: Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
Root cause tag: packaging
FDA 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 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.
Product codes and lots: Lot Number: OCF191255 UDI (01)00813954020884(17)211130(10)OCF191255

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1389-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1389-2019	Class II	Terminated	Voluntary: Firm initiated	2019-05-29	2019-05-22

Product code NPL

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)