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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Musculoskeletal Transplant Foundation, Inc.: DBX Demineralized Bone Matrix Putty Recalled for Mislabeled Fill Volume

Agency Publication Date: November 17, 2023
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Summary

Musculoskeletal Transplant Foundation, Inc. is recalling 18 units of DBX Demineralized Bone Matrix Putty (Model 038100) because the packaging is incorrectly labeled as 10cc, while the actual fill volume is only 1cc. This putty is used by surgeons to treat bone defects caused by surgery or traumatic injury. The significant discrepancy in volume means a surgeon may not have enough material during a procedure, potentially causing the surgery to take longer than expected as they wait for additional supply.

Risk

The incorrect labeling can lead to a surgical delay if the medical team discovers there is insufficient bone matrix putty available mid-procedure. Prolonged surgery increases the duration of anesthesia and the overall risk to the patient during the operation.

What You Should Do

  1. Identify if you have the affected product by checking for DBX Demineralized Bone Matrix Putty 10cc (Model Number: 038100) with GUID W4184038100T0473 and an expiration date of June 20, 2025.
  2. Check the serial number on the packaging against this list of affected numbers: 002220854711400006, 002220854711400056, 002220854711400003, 002220854711400008, 002220854711400009, 002220854711400001, 002220854711400002, 002220854711400010, 002220854711400011, 002220854711400012, 002220854711400013, 002220854711400014, 002220854711400004, 002220854711400005, 002220854711400007.
  3. If you are a healthcare provider or facility in possession of these units, stop using them and quarantine the product immediately.
  4. Contact your healthcare provider or Musculoskeletal Transplant Foundation, Inc. at 125 May St Ste 300, Edison, NJ for instructions on returning the product and receiving a replacement or credit.
  5. For further information or to report issues, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Quarantine and contact manufacturer.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: DBX Demineralized Bone Matrix Putty 10cc
Model / REF:
038100
Lot Numbers:
GUID: W4184038100T0473
002220854711400006
002220854711400056
002220854711400003
002220854711400008
002220854711400009
002220854711400001
002220854711400002
002220854711400010
002220854711400011
002220854711400012
002220854711400013
002220854711400014
002220854711400004
002220854711400005
002220854711400007
Date Ranges: June 20, 2025 (Expiration Date)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93296
Status: Active
Manufacturer: Musculoskeletal Transplant Foundation, Inc.
Sold By: Hospitals; Surgical centers; Medical distributors
Manufactured In: United States
Units Affected: 18 units
Distributed To: Pennsylvania, Texas, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.