FDAFDA · Food and drugs·Recall number 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.
Published August 22, 2012 · Recall initiated: July 5, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is the potential for Hemostatic Bone Putty to ignite if contacted with electrosurgical cautery systems under certain conditions during surgery.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes USA HQ, Inc.
- Distributor
- Worldwide Distribution -- US, including Washington, DC and states of AK, AZ, CA, CT, FL, GA, ID, KS, LA, MD, MA, MI, MN, MO, NE, NH, NY, NC, OH, OR, PA, SC, TX, VA, WA, and WI, and the country of Canada.
- Lot
- All lot numbers associated with the identified part numbers.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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