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U.S. Department of Health and Human Services

Enforcement Report - Week of July 11, 2012

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Product Detail

Product Description Mineralized Bone is labeled in part: "***Processed by: TissueNet***7022 TPC Dr Ste 400***Orlando, FL 32822***Sterilized By: T106^(r) {SAL 10-6}***Tissue ID:***Description: Mineralized Bone***Size 5cc***Product Code MB50050***Expiration***Freeze Dried: Store at 10 C - 37 C***Donated Human Tissue Allograft***Single Patient Use Only***". Full Product Description: Mineralized Bone .125-.85mm 5cc
Recall Number B-1642-12
Classification Class II
Code Info Product ID: TN4211610153, TN4211610154, TN4211610155, TN4211610156, TN4211610158, TN4211610159, TN4211610160, TN4211610161, TN4211610162, TN4211610163, TN4211610164, TN4211610165, TN4211610166, TN4211610167, TN4211610168, TN4211610169, TN4211610170, TN4211610171, TN4211610172, TN4211610173, TN4211610174, TN4211610175, TN4211610176, TN4211610177, TN4211610178, TN4211610179, TN4211610180
Product Distributed Qty 27 ea
Reason For Recall Human allografts, recovered from donors whose donor eligibility may have been determined with inaccurate and/or incomplete donor records, were distributed.

Event Detail

Event Id 60076
Product Type Biologics
Status Ongoing
Recalling Firm Surgical Tissue Network, Inc. dba TissueNet
City Orlando
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-08-25
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Products were distributed to NJ, TX, NH, NY, PR; and to Turkey, Korea, and Chile.