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 risk of harm (foreign material contamination) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Surgical Tissue Network Inc., doing business as TissueNet Inc., has recalled its UltraFill DBM Putty-Porcine products in 1 cc, 5 cc, and 10 cc sizes. The recall was initiated because the products may contain trace amounts of 316L Stainless Steel particulates.
The affected products are identified by Product Code RT53005 and specific Tissue IDs ranging from TN48005-11-0021 through TN74060-11-0056. The recall covers 208 units that were distributed worldwide, including to Turkey, Greece, and Mexico. The product is a donated human tissue allograft intended for single patient use and for international use only.
Consumers and healthcare providers should stop using the affected products immediately. The source text does not provide specific instructions for disposal or return, but users should contact the recalling firm or their healthcare provider for guidance on next steps.
The recalled product
- 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…
- Manufacturer
- Surgical Tissue Network, Inc.
- Hazard
- Affected units
- 208
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 (8)
- 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
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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