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Lower risk Medical device recall · FDA · Published October 30, 2018

Collagen Matrix Inc: 4.0cc Bone Mineral May Be Mislabeled as 2.0cc

Collagen Matrix Inc recalls porcine anorganic bone mineral 4.0cc products that may only contain 2.0cc due to mislabeling. Affected items have specific UDI and lot numbers.

🇺🇸 FDA recall #Z-0752-2019Medical deviceCollagen Matrix ›
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Recalling firmCollagen Matrix Inc15 Thornton Rd · Oakland, NJ 07436-3115
✎ GovInfoNow plain-language explainer

Collagen Matrix Inc is recalling porcine anorganic bone mineral products labeled as 4.0cc that may actually contain only 2.0cc. This mislabeling could lead to incorrect dosing in medical procedures. Read more at govinfonow.com/recall/69545-collagen-matrix-inc-4-0cc-bone-mineral-may-be-mislabeled.

Source Summary by GovInfoNow · govinfonow.com/recall/69545-collagen-matrix-inc-4-0cc-bone-mineral-may-be-mislabeled · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0752-2019

Cite this page

“Collagen Matrix Inc: 4.0cc Bone Mineral May Be Mislabeled as 2.0cc.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69545-collagen-matrix-inc-4-0cc-bone-mineral-may-be-mislabeled. Based on FDA recall #Z-0752-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0752-2019%22&limit=1).

The Food and Drug Administration announced on Oct. 30, 2018, that Collagen Matrix Inc voluntarily recalled Porcine Anorganic Bone Mineral 4.0cc units due to mislabeling hazards. The agency stated the product may contain only 2.0cc of material despite being labeled as 4.0cc.

How to tell if you have it

  • Brand: Collagen Matrix
  • Product: Porcine Anorganic Bone Mineral 4.0cc
  • UPC: 00813954022369
  • Lot Number: PMCU18C4
  • Expiration Date: 04/30/2021
  • Distribution: FL, TX

The hazard

According to the FDA, there is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled.

Context

GovInfoNow's records show Collagen Matrix Inc has five other recalls on record since Aug. 16, 2018. Other recent recalls of similar products include Collagen Dental Wound Dressing Recall (Aug. 3, 2022) and Collagen Matrix DuraMatrix-Onlay Membrane Recall (Dec. 13, 2021).

How to tell if you have this one

Check for the UDI (01)00813954022369(17)210430(10)PMCU18C4 and lot number PMCU18C4 on the product. Products with expiration date 04/30/2021 are affected.

  • Brand
    Collagen Matrix
  • Product
    Porcine Anorganic Bone Mineral 4.0cc
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the UDI (01)00813954022369(17)210430(10)PMCU18C4 and lot number PMCU18C4 on the product.

Where it went and when

Where it was distributed

Distributed in Florida and Texas.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: yesTXFlorida: yesFL

FDA distribution: “FL, TX” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, Texas.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

1. Firm started the recall: Oct 30, 201812. FDA classified it Class III: Jan 17, 201923. Published in FDA’s Enforcement Report: Jan 23, 201934. FDA terminated the recall: May 12, 2020420182020
  1. Firm started the recall
  2. FDA classified it Class III
  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-0752-2019 (October 30, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0752-2019 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