Z-0347-2012

Product is labeled in part - Pouch label: "NanoFUSEDBM***Manufactured and Distributed By...

Name: Z-0347-2012 Product is labeled in part - Pouch label: "***NanoFUSE***DBM***Manufactured and Distributed By...
Creator: Nanotherapeutics, Inc
Published: 2011-03-10
License: https://open.fda.gov/license/

Nanotherapeutics / initiated 2011-03-10 / Terminated / root cause: manufacturing process

FDA source

Nanotherapeutics, Inc began a recall of Product is labeled in part - Pouch label: "***NanoFUSE***DBM***Manufactured and Distributed By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua... on 2011-03-10. The reason FDA records is "On 03/10/2011 Nanotherapeutics Inc, Alachua, FL initiated a recall of their Origen DBM with Bioactive Glass Catalog # 22-2002 (2cc), 22-2005 (5cc) and 22-2010 (10cc). The same product is also distributed as NanoFUSE DBM...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0347-2012
Status: Terminated
Initiated: 2011-03-10
Posted: 2011-12-02
Terminated: 2012-04-03
Recalling firm: Nanotherapeutics
Product: Product is labeled in part - Pouch label: "***NanoFUSE***DBM***Manufactured and Distributed By: Nanotherapeutics, Inc. 13859 Progress Blvd, Suite 300 Alachua, FL 32615 (386) 462-9663***Description: nanoFUSE DBM***Size***Order No.:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***nanotherapeutics***" Product is labeled in part - Carton label: "***nanoFUSE DBM***Order No:***ID***Expiration***nanotherapeutics***Manufactured and Distributed By: Nanotherapeutics, Inc. 13859 Progress Blvd. Suite 300 Alachua, FL 32615***Rx Only***ONE EACH***" NanoFUSE DBM Catalog #: NAN109-02 (2cc size) NAN109-05 (5cc size) NAN109-10(10cc size) "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis).
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: On 03/10/2011 Nanotherapeutics Inc, Alachua, FL initiated a recall of their Origen DBM with Bioactive Glass Catalog # 22-2002 (2cc), 22-2005 (5cc) and 22-2010 (10cc). The same product is also distributed as NanoFUSE DBM Catalog # NAN109-02 (2cc) NAN109-05 (5cc) and NAN109-10(10cc). The products were manufactured without an approved 510k. Direct accounts were notified of the recall on 04/08/2011
Root cause tag: manufacturing process
FDA root cause: No Marketing Application
Action: Nanotherapeutics sent an Urgent: Medical Device Recall letter dated April 12, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to remove any unimplanted/unsold product shipped to them. Customers were asked to notify their customers and instruct them to make notification until the end user (hospital/physician) is reached. Recall Instructions: Immediately examine inventory and quarantine product subject to recall. Return all quarantined product subject to recall to: Nanotherapeutics, Inc. Attn: Receiving Department 13859 Progress Blvd, Suite 300 Alachua, Florida 32615 For questions call 386-462-9663
Quantity in commerce: 131 units
Distribution: Nationwide Distribuiton including TX, FL, AZ, CA, NY, and MA.
Product codes and lots: Catalog # NAN109-02, Lot #: 074349P. Catalog # NAN109-05, Lot #: 073995PA, 077870PB. Catalog # NAN109-10, Lot #: 071045PB, 071043PA, 070916P.

Product code MQV

K110976Class IIOrigen Dbm with Bioactive Glass, Nanofuse DbmNanotherapeutics, Inc. / cleared 2011-05-03

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)