Reported Jan 16, 2013 · Terminated
Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001…
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 Size1cc
- Product CodeRT53001 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
- Product CodeRT53001
- Tissue ID
TN29041-11-0072 Through TN29041-11-0081and TN29041-11-0083 through TN29041-11-0119
- Amount recalled
- 25 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.
Want the full recall guide?
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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