Z-1562-2021Class II

AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects...

Name: Z-1562-2021 AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects...
Creator: Musculoskeletal Transplant Foundation, Inc.
Published: 2021-03-29
License: https://open.fda.gov/license/

Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics / initiated 2021-03-29 / Terminated / root cause: packaging

FDA source

Musculoskeletal Transplant Foundation, Inc. began a recall of AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous defects created from traumatic injury... on 2021-03-29. FDA classified it as Class II and gives the reason as "3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1562-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-29
Posted: 2021-05-12
Terminated: 2023-04-27
Recalling firm: Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics
Product: AFT Straight Tube (3/4 Filled) - Human Allograph Tissue for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine Item Number: 227007
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: 3/4 AFT Straight Fill Tubes (227007) filled only 1/2 way instead of 3/4, may cause delay of surgery
Root cause tag: packaging
FDA root cause: Packaging change control
Action: Musculoskeletal Transplant Foundation (MTF) issued Voluntary Field Action Notification Letter via FedX on March 29, 2021 to the Distributor. Letter states reason for recall, health risk and action to take: As the distributor. Spineology. we will need you to complete notification to your customers and provide the distribution records. questions. Please feel free to contact me at 732-661-2209. or email MTF RegulatoryAffairs at [email protected]
Quantity in commerce: 672 units
Distribution: US Nationwide distribution in the state of MN.
Product codes and lots: Lot/Serial Numbers: 03818070421114 00319018541145 00319022171149 00419019631149 09819009071105 09819036171142

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1562-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1562-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-19	2021-05-12

Product code MQV

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)