Enforcement Report - Week of July 11, 2012
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Product Detail
| Product Description | Fashioned UltraAchilles is labeled in part: "***Sterile {SAL 10-6} T106 Terminal Sterilization System***Tissue ID:***Description Fashioned UltraAchilles***Size***Product Code FF94355***EXPIRATION:***Store at -40 c or Cooler***Donated Human Tissue Allograft***Single Patient Use Only***ID:***Fashioned UltraAchilles***FF94355 EXP:***TissueNet 800-465-8800***" Full Product Description: Fashioned Achilles 9mm |
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| Recall Number | B-1644-12 |
| Classification | Class II |
| Code Info | Product ID: TN4211610071, TN4211610072 |
| Product Distributed Qty | 2 |
| 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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