Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0652-2013 — UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 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

U.S. FDA — Device Enforcement · United States · 2012-03-14 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0652-2013
Date of alert: 2012-03-14
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Surgical Tissue Network, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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