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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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…
- Manufacturer
- Collagen Matrix, Inc.
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
Related recalls
Same manufacturer · Collagen Matrix, Inc.
See all →- HighCollagen Dental Wound Dressing Recalled Due to Potential Sterility Compromise
FDA (Devices) · 2022-10-05
- HighCollagen Dura Substitute Membrane Recalled for Compromised Sterility
FDA (Devices) · 2022-03-02
- HighRESODURA Matrix Onlay Recalled Due to Unsealed Packaging
FDA (Devices) · 2022-03-02
- ModerateCollagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions
FDA (Devices) · 2020-02-05
- ModerateGIBSON Healthcare Membrane Extended Recalled for Incorrect Instructions for Use
FDA (Devices) · 2020-02-05
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateCollagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions
FDA (Devices) · 2020-02-05
- LowCollagen Matrix Recalls BioMend Extend Due to Potential Packaging Error
FDA (Devices) · 2018-11-21
- ModerateGIBSON Healthcare Membrane Extended Recalled for Incorrect Instructions for Use
FDA (Devices) · 2020-02-05
- LowOsteogenics Recalls Cytoplast Membrane Due to Packaging Error
FDA (Devices) · 2016-10-26
- ModerateGIBSON Healthcare Membrane Recalled for Incorrect Instructions for Use
FDA (Devices) · 2020-02-05
- HighIntegra Recalls OraMem Absorbable Collagen Membrane Due to Pyrogen Levels
FDA (Devices) · 2013-05-22