Enforcement Report - Week of July 11, 2012
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Product Detail
| Product Description | UltraC1 or C2, Cervical is labeled in part: "***Expiration***Freeze Dried: Store at 10 C - 37 C***Sterilization Method: T106 Terminal Sterilization System***Donated Human Tissue Allograft / Sterile {SAL 10-6, Non-Irradiated***Single Patient Use Only***". Small label: "***ID:***UltraC1, Cervical***FD57506, 6mm Small label: "***ID:***UltraC1, Cervical***FD57507, 7mm Small label: "***ID:***UltraC1, Cervical***FD57508, 8mm Small label: "***ID:***UltraC2, Cervical***FD57607, 7mm |
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| Recall Number | B-1637-12 |
| Classification | Class II |
| Code Info | Product ID: FD57506, 6mm TN4211610002, TN4211610003, TN4211610004, TN4211610005, TN4211610006 TN4211610007, TN4211610008 Product ID: FD57507, 7mm TN4211610009, TN4211610010, TN421161001, TN4211610012, TN4211610013 TN4211610014 Product ID: FD57508, 8mm TN4211610015 Product ID: FD57607, 7mm TN4211610029, TN4211610030, TN4211610031, TN4211610032, TN4211610033 |
| Product Distributed Qty | 19 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. |
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