Reported Jan 16, 2013 · Terminated
UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 5cc Product Code: RT53005…
Surgical Tissue Network, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Surgical Tissue Network, Inc. · 7022 TPC Dr Ste 400 · Orlando, FL · 32822-5140
Is this the product you have?
- UltraFill DBM labeled in partTISSUENET Sterilized by T10^6
- DescriptionUltraFill
- DBM Size5cc
- Product CodeRT53005 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
- Lot codes and dates
8 of 8 products
Products covered by this recall Model / number Product as published RT53005Tissue 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 - Amount recalled
- 208 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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