Musculoskeletal Transplant Foundation, Inc. AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
Brand
Musculoskeletal Transplant Foundation, Inc.
Lot Codes / Batch Numbers
UDI-DI: W4184227005T0473 Donor Lots 00322029241137 and 00322039641144
Products Sold
UDI-DI: W4184227005T0473 Donor Lots 00322029241137 and 00322039641144
Musculoskeletal Transplant Foundation, Inc. is recalling AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler) due to Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudabilit. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
Recommended Action
Per FDA guidance
The firm notified their distributor of the issue during a meeting on December 22, 2023. A notification letter was also issued to the distributor. If the device/tissue was transplanted, no further action is warranted. However, if the device/tissue is still available in the customer's inventory, the unit shall be returned to Spineology, the distributor. Should you have any questions, please contact the firm at 732-661-2209, or email MTF Regulatory Affairs at Regulatory_Customer_Inquiry@mtf.org.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MN
Page updated: Jan 10, 2026