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Lower risk Medical device recall · FDA · Published March 19, 2019

Collagen Matrix Neomem Resorbable Collagen Membrane Recall: Wrong Packaging Risk

Collagen Matrix recalls Neomem Resorbable Collagen Membrane (N1520) due to incorrect packaging. This may lead to improper use in dental procedures. Affected units include specific lot numbers.

🇺🇸 FDA recall #Z-1389-2019Medical deviceCollagen Matrix ›
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Recalling firmCollagen Matrix, Inc.110 Commerce Dr · Allendale, NJ 07401-1622
✎ GovInfoNow plain-language explainer

What happened, in plain English

Collagen Matrix is recalling Neomem Resorbable Collagen Membrane (15 mm x 20 mm, model N1520) because it was packaged in the wrong box. This could cause improper use during dental surgery, potentially affecting wound healing. Read more at govinfonow.com/recall/68605-collagen-matrix-neomem-resorbable-collagen-membrane-recall-wrong-packaging-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/68605-collagen-matrix-neomem-resorbable-collagen-membrane-recall-wrong-packaging-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1389-2019

Cite this page

“Collagen Matrix Neomem Resorbable Collagen Membrane Recall: Wrong Packaging Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68605-collagen-matrix-neomem-resorbable-collagen-membrane-recall-wrong-packaging-risk. Based on FDA recall #Z-1389-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1389-2019%22&limit=1).

Why it’s dangerous

The product was mistakenly placed inside a Neomem FLEXPLUS box instead of a standard Neomem box. This packaging error could lead to incorrect usage during dental surgery, potentially affecting wound healing outcomes.

Who’s affected

Dental surgeons and patients using Neomem for dental procedures are affected. Those with the specific lot number OCF191255 are most at risk.

How to tell if you have this one

Check for the model number N1520 on the product label. The lot number OCF191255 is associated with this recall. The product is used in dental procedures for wound healing after surgery.

  • Brand
    Collagen Matrix
  • Product
    Collagen Matrix, Inc. recalls Neomem Resorbable Collagen Membrane, 15 mm x 20 mm Reference Number (model): N1520
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Packaging

    Look for the model number N1520 and lot number OCF191255 on the product label.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 2 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: named in the noticeFL

FDA distribution: “Worldwide distribution - US nationwide in the states of CA, FL and countries of Canada, Israel.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida.

Recall timeline

FDA terminated this recall 14 months after the firm started it.

1. Firm started the recall: Mar 19, 201912. FDA classified it Class II: May 22, 201923. Published in FDA’s Enforcement Report: May 29, 201934. FDA terminated the recall: May 12, 2020420192020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1389-2019 (March 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1389-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA