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Lower risk Medical device recall · FDA · Published August 16, 2018

BioMend Extend Synthetic Bone Graft Recall: Wrong Box Packaging Risk

Collagen Matrix recalls BioMend Extend synthetic bone graft material due to possible wrong box packaging. The product may be placed inside a BioMend box instead of BioMend Extend box, but labels and instructions are correct.

🇺🇸 FDA recall #Z-0414-2019Medical deviceCollagen Matrix ›
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Contact the company

Recalling firmCollagen Matrix, Inc.110 Commerce Dr · Allendale, NJ 07401-1622
✎ GovInfoNow plain-language explainer

Collagen Matrix is recalling BioMend Extend synthetic bone graft material because it might be packaged in the wrong box. This could cause confusion but does not affect the product's safety or instructions. Read more at govinfonow.com/recall/70018-biomend-extend-synthetic-bone-graft-recall-wrong-box-packaging-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/70018-biomend-extend-synthetic-bone-graft-recall-wrong-box-packaging-risk · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0414-2019

Cite this page

“BioMend Extend Synthetic Bone Graft Recall: Wrong Box Packaging Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70018-biomend-extend-synthetic-bone-graft-recall-wrong-box-packaging-risk. Based on FDA recall #Z-0414-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0414-2019%22&limit=1).

The FDA announced on August 16, 2018, that Collagen Matrix Inc. is recalling BioMend Extend synthetic bone grafting material because the product may have been packaged in the wrong box. The agency stated the hazard involves potential confusion between BioMend and BioMend Extend packaging.

How to tell if you have it

  • Brand: Collagen Matrix
  • Product: BioMend Extend, REF# 0142Z
  • Lot codes: CDMEN18F1, CDMEN18F3
  • Quantity: 569 units
  • Distribution: One distributor in Florida

The hazard

According to the FDA, there is a possibility that the product was packaged in the wrong box, specifically inside a BioMend box instead of a BioMend Extend box. The agency noted that the only difference between the two boxes is the product trade name, while the label and Instructions for Use remain correct.

Context

GovInfoNow's records show Collagen Matrix Inc has issued five other recalls since October 30, 2018. Other recent recalls of similar products include Collagen Dental Wound Dressing Recall (2022-08-03), Collagen Matrix DuraMatrix-Onlay Membrane Recall (2021-12-13), and Collagen Matrix GIBSON Healthcare Membrane Recall (2019-11-05). Other recent recalls of similar products include Biomet Intramedullary Bone Saw Blade Recall (2026-07-01), Straumann GM Helix Dental Implant Recall (2026-07-13), and another Biomet Intramedullary Bone Saw Blade Recall (2026-07-01).

How to tell if you have this one

Check the box label for the product trade name. The correct BioMend Extend box should have the trade name 'BioMend Extend' on it. The product was sold with reference numbers CDMEN18F1 and CDMEN18F3.

  • Brand
    Collagen Matrix
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Box Label

    Look for the product trade name on the box to confirm it's BioMend Extend, not BioMend.

Where it went and when

Where it was distributed

Distributed in Florida.

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: not listedTXFlorida: yesFL

FDA distribution: “Distributed to one distributor located in Florida.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

1. Firm started the recall: Aug 16, 201812. FDA classified it Class III: Nov 9, 201823. Published in FDA’s Enforcement Report: Nov 21, 201834. FDA terminated the recall: Jun 23, 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-0414-2019 (August 16, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0414-2019 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