FDAFDA · Food and drugs·Recall number Z-0953-2013
Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
Published March 27, 2013 · Recall initiated: February 1, 2013
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
A dimensional mismatch was identified which can potentially allow for interference between devices.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Exactech, Inc.
- Distributor
- Nationwide Distribution including the states of FL, AL, LA, PA, VA, IL, OH, NY, NC, KS, TN, NJ, CO, GA, CA, MD, MN, IN, & Puerto Rico.
- Lot
- Catalog # 02-012-42-3508 All lot numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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