TissueNet Recalls UltraFill DBM Putty Due to Stainless Steel Particulates
Surgical Tissue Network, Inc. recalled UltraFill DBM Putty-Porcine because 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 object hazard (stainless steel particulates) where injury has not yet been reported, fitting the High severity criteria for risk-of-harm products.
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 RT53010 and specific Tissue IDs ranging from 07-175-330 through 07-175-359, TN61032-11-0017 through TN61032-11-0041, TN62034-11-0001 through TN62034-11-0024, TN62053-11-0155 through TN62053-11-0209, TN67049-11-0291 through TN67049-11-0316, TN70037-11-0020 through TN70037-11-0037, and TN74060-11-0021 through TN74060-11-0047 and TN74060-11-0050 through TN74060-11-0056. A total of 160 units were involved in this recall.
The products were distributed worldwide, including in Turkey, Greece, and Mexico. Healthcare providers and patients should check their inventory and patient records for these specific product codes and tissue IDs. If the product has been used, patients should contact their healthcare provider for evaluation.
The recalled product
- Product
- UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 10cc Product Code: RT53010 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
- 160
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: RT53010 Tissue ID: 07-175-330 through 07-175-359
- TN61032-11-0017 through TN61032-11-0041
- TN62034-11-0001 through TN62034-11-0024
- TN62053-11-0155 through TN62053-11-0209
- TN67049-11-0291 through TN67049-11-0316
- 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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