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.
Z-1389-2019
Product summary
- Event
- Event 82638
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45 units -US;170 units OUS
- Official record key
device-enforcement:Z-1389-2019
Official wording
Reason: Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box
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.
Derived failure modes
-
Unknown
Product was packaged in the wrong box; may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box