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Collagen Matrix, Inc. recalls Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a bioreso
Recalled May 29, 2019 · FDA recall Z-1389-2019 · Collagen Matrix
Hazard
Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box · FDA Class II
Units
45 units -US;170 units OUS
Sold at
Worldwide distribution - US nationwide in the states of CA, FL and countries of Canada, Israel.
Description
Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
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.
Manufacturer(s)
Collagen Matrix, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →