Z-1067-2024Class II

AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)

Name: Z-1067-2024 AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
Creator: Musculoskeletal Transplant Foundation, Inc.
Published: 2023-12-22
License: https://open.fda.gov/license/

Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics / initiated 2023-12-22 / Open, Classified / root cause: manufacturing process

FDA source

Musculoskeletal Transplant Foundation, Inc. began a recall of AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler) on 2023-12-22. FDA classified it as Class II and gives the reason as "Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1067-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-22
Posted: 2024-02-09
Recalling firm: Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics
Product: AFT (Allograft Filler Tube) Diverted Tube (3/4 Filled), Product Code 227005 (bone void filler)
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: Filling process qualification did not demonstrate adequate process capability. Possible consequences include extended surgery time due to extrudability issues.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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 [email protected].
Quantity in commerce: 50
Distribution: Product was distributed to Minnesota.
Product codes and lots: UDI-DI: W4184227005T0473 Donor Lots 00322029241137 and 00322039641144

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1067-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1066-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-09
Z-1067-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-21	2024-02-09

Product code MQV

K042125Class IIAftMusculoskeletal Transplant Foundation / cleared 2005-07-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)