FDAFDA · Food and drugs·Recall number Z-2289-2014
PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and protect its contents from damage consistent with typical hospital or surgical center circulation (i.e. between central services and the operating room) and during transport between a Zimmer distributorship and a health care facility by Zimmer distributorship personnel.
Published August 27, 2014 · Recall initiated: July 1, 2014
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
The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper position/orientation. The drill bracket and drill guide are not the correct geometry to allow for a proper fit in the Persona Fixed Case Kit which could lead to improper sterilization of the tibial drill and stop guide.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- Worldwide Distribution - USA including AZ, CA, CO, FL, IL, IN, KS, MI, MN, NC, NJ, NY, OH, OR, PA, TN, TX & VA and Internationally to AUSTRALIA, FRANCE, INDIA, ITALY, and GERMANY.
- Lot
- Item Number 00-5908-015-00, Lot Numbers: 56519125 & 56518861
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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