Collagen Matrix, Inc. recalls Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioreso…

Recall date

March 19, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1389-2019

FDA classification

Class II

Brand / firm

Collagen Matrix, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.