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U.S. Department of Health and Human Services

Enforcement Report - Week of January 16, 2013

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Event Detail

Event ID 63226
Product Type Devices
Status Ongoing
Recalling Firm Surgical Tissue Network, Inc.
City Orlando
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-03-14
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution including Turkey, Greece, & Mexico.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
UltraFill DBM labeled in part: ***TISSUENET***Sterilized by T10^6 (r)***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 Porcine DBM product line is used as a bone void filler. 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 Class II 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. 160 units Z-0653-2013
UltraFill DBM labeled in part: ***TISSUENET***Sterilized by T10^6 (r)***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 Porcine DBM product line is used as a bone void filler. 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 Class II 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. 208 units Z-0652-2013
Ultrafill DBM labeled in part: ***TISSUENET***Sterilized by T10^6 (r)***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 DBM product line is used as a bone void filler Product Code: RT53001 Tissue ID: TN29041-11-0072 Through TN29041-11-0081; and TN29041-11-0083 through TN29041-11-0119 Class II 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. 25 units Z-0651-2013
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