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

Recall Z-2206-2012 — Synthes(R) Hemostatic Bone Putty, Part numbers 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, and VB1025.10S. Indicated for use as a water soluble implant material and for use in the control of bleeding from bone surfaces.

U.S. FDA — Device Enforcement · United States · 2012-07-05 · Class I

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2206-2012
Date of alert
2012-07-05
Country / jurisdiction
United States
Risk level
Class I
Risk type
recall
Brand
Synthes USA HQ, Inc.
Product category
device
Product type
Devices
Reported risk: There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.
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.

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