Z-1455-2015Class II

DBX Mix, 20 cc

Name: Z-1455-2015 DBX Mix, 20 cc
Creator: Musculoskeletal Transplant Foundation, Inc.
Published: 2014-12-04
License: https://open.fda.gov/license/

Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics / initiated 2014-12-04 / Terminated / root cause: packaging

FDA source

Musculoskeletal Transplant Foundation, Inc. began a recall of DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler on 2014-12-04. FDA classified it as Class II and gives the reason as "The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above may not be fully intact". 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-1455-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-04
Posted: 2015-04-17
Terminated: 2017-05-08
Recalling firm: Musculoskeletal Transplant Foundation d/b/a/ MTF Biologics
Product: DBX Mix, 20 cc, Product Code: 058200. Demineralized Bone Matrix Mix, bone void filler.
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: The seal on the DBX Mix outer PETG/Aclar tray with foil lid packaging for lot identified above may not be fully intact.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: MTF notified their customers on 12/4/2014 and 12/8/2014 via phone and letter.
Quantity in commerce: 25 units
Distribution: US Nationwide distribution to CA, KY, IL, LA, PA, NC, TN, WV, and Puerto Rico.
Product codes and lots: 064130067910690008; 064130067910690009; 064130067910690004; 064130067910690023; 064130067910690024 064130067910690005; 064130067910690015; 064130067910690016; 064130067910690018; 064130067910690020; 064130067910690007; 064130067910690013; 064130067910690028; 064130067910690029; 064130067910690030; 064130067910690010; 064130067910690006; 064130067910690011; 064130067910690012; 064130067910690019; 064130067910690021; 064130067910690014; 064130067910690017; 064130067910690001; 064130067910690022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1455-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1455-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-17

Product code MQV

K040262Class IIDbx Demineralized Bone Matrix Putty, Bone Matrix Paste and Bone Matrix MixMusculoskeletal Transplant Foundation / cleared 2005-03-17

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)