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Musculoskeletal Transplant Foundation

FDA registration: United States Last updated 26 Oct 2026

Devices
73
Registries
GUDIDFDA 510(k)
FDA recalls
93 ongoing

Catalogue73

Page 1 of 2

Showing 1-50 of 73

FDA recalls9

Device pages show only the recalls that name the device or its 510(k)/PMA.

FDA recall records list 9 recalls initiated by Musculoskeletal Transplant Foundation, the earliest on 2014-12-04 and the most recent on 2023-12-22. By recorded status: 3 ongoing and 6 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company. Generated automatically from FDA recall records.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2023

    • 22 Dec 2023 Z-1066-2024 Class II Ongoing Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
    • 22 Dec 2023 Z-1067-2024 Class II Ongoing Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
    • 22 Sep 2023 Z-0323-2024 Class II Ongoing Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.

  • 2021

    • 29 Mar 2021 Z-1562-2021 Class II Terminated 3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery

  • 2019

    • 15 Aug 2019 Z-2548-2019 Class II Terminated Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure.

  • 2016

    • 21 Apr 2016 Z-2004-2016 Class II Terminated AFT Diverted Tubes are being recalled due to a customer complaint involving one unit which had an unsealed Tyvek pouch. The non-sterile foil pouch may introduce contamination into the sterile field.

  • 2015

    • 27 May 2015 Z-2075-2015 Class II Terminated Musculoskeletal Transplant Foundation is recalling a certain lot of Allofix Insertion Kits because they are labeled as having a 2.0mm diameter drill however it may contain a 2.4 mm diameter drill.
    • 27 May 2015 Z-2210-2015 Class II Terminated Musculoskeletal Transplant Foundation (MTF) is recalling one lot of MTF's Allograft Cortical Pins because the lot was labeled as a 2.0 mm diameter pin and it may contain a 2.4 mm diameter pin.

  • 2014

    • 4 Dec 2014 Z-1455-2015 Class II Terminated The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above may not be fully intact.

About

MTF Biologics offers a fully-digital online ordering platform to request matched grafts. Upload your films within seconds, receive instant confirmation, and connect with our team throughout the process. For our large grafts, meniscal and fresh osteochondral allografts, MTF Biologics graft matching provides orthopedic surgeons with the best anatomically-matched allograft tissue for their patients, eliminating extensive modifications during transplantation and saving valuable surgical time.

From the manufacturer's own website. Source

What Musculoskeletal Transplant Foundation makes

The Musculoskeletal Transplant Foundation produces human-derived bone matrix implants, including demineralized bone matrix (DBM) products like DBX®, and tendon grafts for orthopedic applications. It also supplies single-use general-purpose syringes for clinical use in surgical procedures.

These products are regulated under FDA Class I and Class II classifications, with authorizations recorded via 510(k) submissions and the FDA’s Unique Device Identifier (UDI) system. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

How many devices does Musculoskeletal Transplant Foundation have in the registry?

The registry currently lists 73 devices for Musculoskeletal Transplant Foundation. Devices recorded under merged duplicate company entries are counted once.

Which registries list Musculoskeletal Transplant Foundation's devices?

Among its 50 most recently registered devices, Musculoskeletal Transplant Foundation has devices listed in FDA 510(k) (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Musculoskeletal Transplant Foundation's devices fall under?

Among its 50 most recently registered devices, the classes recorded for Musculoskeletal Transplant Foundation's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Musculoskeletal Transplant Foundation?

FDA recall records list 9 recalls initiated by Musculoskeletal Transplant Foundation, the most recent initiated on 2023-12-22. 3 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Musculoskeletal Transplant Foundation in the registry?

The most recently registered devices listed for Musculoskeletal Transplant Foundation include DBX® 058150, DBX® 048015, DBX® 038025 and DBX® 068025.

Generated automatically from registry data and not verified by a human reviewer.

Information

FDA registration
United States(from the FDA device records)
Email
[email protected](from company website)