CLASS II Device recall · Reported 16 Jan 2013 · FDA Enforcement Report

Ultrafill DBM labeled in part recalled by Surgical Tissue Network

Surgical Tissue Network is recalling Ultrafill DBM labeled in part: Tissuenet Sterilized by T10^6 Description: UltraFill DBM. The recall was initiated on 14 Mar 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code: RT53001 Tissue ID: TN29041-11-0072 Through TN29041-11-0081; and TN29041-11-0083 through TN29041-11-0119

Quantity recalled25 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0651-2013
FDA event ID: 63226
Recalling firm: Surgical Tissue Network, Orlando, FL
Classification: Class II
Status: Terminated
Recall initiated: 14 Mar 2012
FDA classified: 7 Jan 2013
Reported: 16 Jan 2013
Type: Voluntary: Firm initiated
Reason category: Particulate Matter
Device type: Other Medical Devices

Timeline

14 Mar 2012	Recall initiated by company
7 Jan 2013	Classified by FDA	+299 days
16 Jan 2013	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 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

Where it was distributed

Worldwide Distribution including Turkey, Greece, & Mexico.

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Product Code: RT53001 Tissue ID: TN29041-11-0072 Through TN29041-11-0081; and TN29041-11-0083 through TN29041-11-0119

Where was it sold?

Worldwide Distribution including Turkey, Greece, & Mexico.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 63226

This product is part of a recall event; the main page for the event is UltraFill DBM labeled in part recalled by Surgical Tissue Network.

Reported	Class	Recall	Company	Reason	Where
16 Jan 2013	CLASS II	UltraFill DBM labeled in part recalled by Surgical Tissue Network	Surgical Tissue Network	Particulate Matter	FL
16 Jan 2013	CLASS II	UltraFill DBM labeled in part recalled by Surgical Tissue Network	Surgical Tissue Network	Particulate Matter	FL

More recalls from Surgical Tissue Network

All 3

Reported	Class	Recall	Company	Reason	Where
16 Jan 2013Device	CLASS II	UltraFill DBM labeled in part recalled by Surgical Tissue Network	Surgical Tissue Network	Particulate Matter	FL
16 Jan 2013Device	CLASS II	UltraFill DBM labeled in part recalled by Surgical Tissue Network	Surgical Tissue Network	Particulate Matter	FL

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