FDA Medical Device Recalls (openFDA)
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 moderate to severe periodontal disease as a material for placement in periodontal defects to aid in wound healing of periodontal tissue.
- Recall number
- Z-1389-2019
- 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.
- Status
- Terminated
- Initiated
- 2019-03-19
- Posted
- not on file
- Terminated
- 2020-05-12
- 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 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
- 45 units -US;170 units OUS
- Distribution
- Worldwide distribution - US nationwide in the states of CA, FL and countries of Canada, Israel.
- Lot, serial or model codes
- Lot Number: OCF191255 UDI (01)00813954020884(17)211130(10)OCF191255
- 510(k) numbers
- ["K003339","K011695"]
- PMA numbers
- not on file
- Product code
- NPL
- Firm FEI
- 3003300673
- Firm city
- Allendale
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28