FDAFDA · Food and drugs·Recall number Z-1377-2013
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
Published June 5, 2013 · Recall initiated: March 4, 2011
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
Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Anspach Effort, Inc.
- Distributor
- Worldwide Distribution-USA (nationwide) including DC and the states of OH, TX, IL, CA, GA, KY, FL, WI, NC, VA, WI, MN, MD, KS, OK, PA, OR ,HI, AZ, WA, TN, AR, IA, MI, CO, LA, NJ, IN, WV, MO, AL, NY, VT, and SC and the countries of France, Canada, Great Britain, Mexico, Australia, Sweden and Netherlands.
- Lot
- Lots numbers: D433040800, D403040236, D383039472.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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