Z-2004-2016Class II

Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of...

Name: Z-2004-2016 Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of...
Creator: Musculoskeletal Transplant Foundation, Inc.
Published: 2016-04-21
License: https://open.fda.gov/license/

Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics / initiated 2016-04-21 / Terminated / root cause: packaging

FDA source

Musculoskeletal Transplant Foundation, Inc. began a recall of Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created... on 2016-04-21. FDA classified it as Class II and gives the reason as "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". 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-2004-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-21
Posted: 2016-06-16
Terminated: 2016-10-18
Recalling firm: Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics
Product: Musculoskeletal Transplant Foundation, AFT Diverted Tube (3/4/Filled), indicated for treatment of surgically-created osseous defects or osseous defects created from traumatic injury. It can be used in the: extremities, pelvis, and spine. Product Code: 227005.
Product code: MBP Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Reason for recall: 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.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Musculoskeletal Transplant Foundation (MTF) sent an Voluntary Field Action Notification Letter dated April 21, 2016, and via telephone to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were notified of the situation with the product and provided instructions on how to handle the product. Questions can be directed to Customer Service Customer at 1-800-433-6576.
Quantity in commerce: 114 units
Distribution: nationwide
Product codes and lots: Serial 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122 04314046801122

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2004-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2004-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-13	2016-07-07

Product code MBP

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)