RegWardenFDA facility compliance records
Facility

Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics

8 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2014: 1 recalls; 2015: 2 recalls; 2016: 1 recalls; 2019: 1 recalls; 2021: 1 recalls; 2023: 2 recalls1’142’151’16’17’181’19’201’21’222’23’24’25’26
  • Recalls (8)

Devices registered here (1)

Recalls & enforcement

  • Class IIOngoing2023-12-22
    Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
  • Class IIOngoing2023-09-22
    Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in prolongation of surgery.
  • Class IITerminated2021-03-29
    3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery
  • Class IITerminated2019-08-15
    Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure.
  • Class IITerminated2016-04-21
    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.
  • Class IITerminated2015-05-27
    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.
  • Class IITerminated2015-05-27
    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.
  • Class IITerminated2014-12-04
    The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above may not be fully intact.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics (FEI 1000307092) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000307092-musculoskeletal-transplant-foundation-d-/

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