TissueNet Recalls UltraFill DBM Putty Due to Stainless Steel Particulates
Surgical Tissue Network Inc. is recalling UltraFill DBM Putty-Porcine because the products may contain trace amounts of 316L Stainless Steel particulates.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential foreign material contamination (stainless steel particulates) which poses a risk of harm, but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Surgical Tissue Network Inc., doing business as TissueNet Inc., has issued a recall for its UltraFill DBM Putty-Porcine products in 1 cc, 5 cc, and 10 cc sizes. The recall is being conducted because the products may contain trace amounts of 316L Stainless Steel particulates.
The affected products are identified by Product Code RT53001 and specific Tissue IDs ranging from TN29041-11-0072 through TN29041-11-0081 and TN29041-11-0083 through TN29041-11-0119. The recall covers 25 units that were distributed worldwide, including to Turkey, Greece, and Mexico. The products are labeled as 'Donated Human Tissue Allograft' and 'SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY.'
Healthcare providers and patients should stop using the affected UltraFill DBM Putty-Porcine products immediately. Users should check their inventory for the specific product codes and tissue IDs listed in the recall notice. For further information, contact the recalling firm or refer to the FDA recall database.
The recalled product
- Product
- 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…
- Manufacturer
- Surgical Tissue Network, Inc.
- Affected units
- 25
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Code: RT53001 Tissue ID: TN29041-11-0072 Through TN29041-11-0081
- and TN29041-11-0083 through TN29041-11-0119
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by Surgical Tissue Network, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Surgical Tissue Network, Inc.
See all →- HighTissueNet Recalls UltraFill DBM Putty Due to Stainless Steel Particulates
FDA (Devices) · 2013-01-16
- HighTissueNet Recalls UltraFill DBM Putty Due to Stainless Steel Particulates
FDA (Devices) · 2013-01-16
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