FDA recall Z-1389-2019

Collagen Matrix, Inc. · Class II · device

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.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-03-19
Report date
2019-05-29
Termination date
2020-05-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Allendale, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1389-2019