FDAFDA · Food and drugs·Recall number Z-1032-2017
Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6
Published January 25, 2017 · Recall initiated: November 7, 2016
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
Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Exactech, Inc.
- Distributor
- AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.
- Lot
- Serial No. 3787445-3787447, 3868023-3868072, 4209114-4209135, 4318092-4318102, 4350860-4350869, 4386939, 4420620-4420644, 4558261-4458262; Catalog No. 162-00-06; UDI: 10885862262776
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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