Z-0652-2013Class II

UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc

Name: Z-0652-2013 UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc
Creator: Surgical Tissue Network, Inc.
Published: 2012-03-14
License: https://open.fda.gov/license/

Surgical Tissue Network, Inc. / initiated 2012-03-14 / Terminated / root cause: manufacturing process

FDA source

Surgical Tissue Network, Inc. began a recall of UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc Product Code: RT53005 Donated Human Tissue Allograft SINGLE... on 2012-03-14. FDA classified it as Class II and gives the reason as "Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates". 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-0652-2013
Classification: Class II
Status: Terminated
Initiated: 2012-03-14
Posted: 2013-01-07
Terminated: 2014-12-02
Recalling firm: Surgical Tissue Network, Inc.
Product: UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc Product Code: RT53005 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler.
Product code: MQV Filler, Bone Void, Calcium Compound
Reason for recall: Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc; 5cc; 10cc) because products may contain trace amounts of 316L Stainless Steel particulates.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Surgical Tissue Network sent a Notification of Voluntary Tissue Recall dated March 22, 2012, to all affected customers. The firm issued an additional notification letter on August 30, 2012. The letter identified the product, the problem, and action to be taken by the customer. Consignees were asked to return all listed products that remain in inventory. If the product was further distributed, they were asked to forward the recall information to their customers. Customers were instructed to contact TissueNet's Customer Service Department at 800-465-8800 x283 to coordinate return/replacement of the affected product. Customers with questions were instructed to call 800-465-8800 x230. For questions regarding this recall call 407-380-2424.
Quantity in commerce: 208 units
Distribution: Worldwide Distribution including Turkey, Greece, & Mexico.
Product codes and lots: Product Code: RT53005 Tissue ID: TN48005-11-0021 through TN48055-11-0059; TN48055-11-0070 through TN48055-11-0075; TN58063-11-0101 through TN58063-11-0142; TN61039-11-0031 through TN61039-11-0097; TN70037-11-0017 through TN70037-11-0018; TN70037-11-0020 through TN70037-11-0037; TN74060-11-0021 through TN74060-11-0047; TN74060-11-0050 through TN74060-11-0056

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0652-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0651-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-07
Z-0652-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-07
Z-0653-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-16	2013-01-07

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)