Collagen Matrix, Inc.: Medical Device Recall in 2019 - (Recall #: Z-1389-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: March 19, 2019

Date Posted: May 29, 2019

Recall Number: Z-1389-2019

Event ID: 82638

Reason for Recall:

Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box

Status: Terminated

Product Quantity: 45 units -US;170 units OUS

Code Information:

Lot Number: OCF191255 UDI (01)00813954020884(17)211130(10)OCF191255

Distribution Pattern:

Worldwide distribution - US nationwide in the states of CA, FL and countries of Canada, Israel.

Voluntary or Mandated:

Voluntary: Firm initiated