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U.S. Department of Health and Human Services

Class 2 Device Recall Origen DBM with Bioactive Glass

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 Class 2 Recall
Origen DBM with Bioactive Glass
see related information
Date Posted December 02, 2011
Recall Status1 Terminated on April 03, 2012
Recall Number Z-0347-2012
Recall Event ID 60335
Premarket Notification
510(K) Number
K110976 
Product Classification Filler, Bone Void, Calcium Compound - Product Code MQV
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).
Code Information Catalog # NAN109-02, Lot #: 074349P. Catalog # NAN109-05, Lot #: 073995PA, 077870PB. Catalog # NAN109-10, Lot #: 071045PB, 071043PA, 070916P.
Recalling Firm/
Manufacturer
Nanotherapeutics, Inc
13859 Progress Blvd Ste 300
Alachua, Florida 32615-9403
For Additional Information Contact Barb Eppler
386-462-9663
Manufacturer 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
FDA Determined
Cause 2
PREMARKET APPROVAL: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MQV and Original Applicant = NANOTHERAPEUTICS, INC.
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