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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.: AFT Allograft Filler Tubes Recalled for Potential Extrudability Issues

Agency Publication Date: February 9, 2024
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Summary

Musculoskeletal Transplant Foundation, Inc. is recalling 139 units of AFT (Allograft Filler Tube) bone void filler because the filling process did not meet quality standards. This defect can make the bone graft material difficult to push out of the tube during medical procedures. This issue affects both the AFT Straight Tube (Product Code 227010) and the AFT Diverted Tube (Product Code 227005) distributed to Minnesota.

Risk

The defect may cause the filler material to be difficult to extrude from the device, which could lead to extended surgery times while medical staff address the issue during a procedure.

What You Should Do

  1. Check your medical inventory for AFT (Allograft Filler Tube) Straight Tube (1/2 Filled), Product Code 227010, specifically Donor Lot 02921115411127 with UDI-DI: W4184227010T0473.
  2. Check your medical inventory for AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005, specifically Donor Lots 00322029241137 and 00322039641144 with UDI-DI: W4184227005T0473.
  3. Immediately identify and quarantine any affected units to ensure they are not used in surgical procedures.
  4. Contact your healthcare provider or the Musculoskeletal Transplant Foundation, Inc. at 125 May St Ste 300, Edison, NJ 08837 for further instructions regarding the return or replacement of these devices.
  5. For more information or to report concerns, contact the FDA directly at 1-888-463-6332 or visit their website at www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer contact for medical device instruction.

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

Affected Products

Product: AFT (Allograft Filler Tube) Straight Tube (1/2 Filled)
Model / REF:
Product Code 227010
W4184227010T0473 (UDI-DI)
Lot Numbers:
Donor Lot 02921115411127
Product: AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled)
Model / REF:
Product Code 227005
W4184227005T0473 (UDI-DI)
Lot Numbers:
Donor Lot 00322029241137
00322039641144

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93853
Status: Active
Manufacturer: Musculoskeletal Transplant Foundation, Inc.
Manufactured In: United States
Units Affected: 2 products (89; 50)
Distributed To: Minnesota
Agency Last Updated: February 28, 2024

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.