Reported May 29, 2019 · Terminated
Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520 - Product Usage: Neomem is a…
Collagen Matrix, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Collagen Matrix, Inc. · 110 Commerce Dr · Allendale, NJ · 07401-1622
Is this the product you have?
- Neomem Resorbable Collagen Membrane, 15
- mm x 20 mm Reference Number (model)N1520 -
- Product UsageNeomem 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
- Lot codes and dates
- Lot NumberOCF191255 UDI (01)00813954020884(17)211130(10)OCF191255
- Amount recalled
- 45 units -US;170 units OUS
Where it was sold
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
This product could cause temporary or reversible health problems — stop using it.
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