The Recall Desk
LowFDA (Devices)·Z-1389-2019·Announced 2019-05-29

Collagen Matrix Recalls Neomem Membrane Due to Incorrect Packaging

Collagen Matrix, Inc. is recalling Neomem Resorbable Collagen Membranes because they were packaged in the wrong box, potentially inside a Neomem FLEXPLUS box.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is for a packaging-only problem (wrong box) with no reported injuries or illnesses, fitting the 'Low' severity criteria for cosmetic or documentation issues.

Plain-English summary

Collagen Matrix, Inc. is recalling Neomem Resorbable Collagen Membranes (15 mm x 20 mm, Reference Number N1520) due to a packaging error. The product was packaged in the wrong box and may have been placed inside a Neomem FLEXPLUS box instead of a Neomem box.

The recall involves 45 units in the United States and 170 units outside the United States. Distribution was worldwide, including nationwide in the US states of California and Florida, as well as in Canada and Israel. The specific lot number is OCF191255.

Neomem is a bioresorbable, implantable collagen material intended for use in dental surgery procedures to aid in wound healing. Consumers and healthcare providers should check their inventory for this specific lot number and packaging discrepancy. No specific instructions for disposal or return are provided in the source text.

The recalled product

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 defe

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: OCF191255 UDI (01)00813954020884(17)211130(10)OCF191255

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically: