Z-2289-2014 Class II Terminated
FDA device recall Z-2289-2014 was initiated by Zimmer, Inc. on Jul 1, 2014 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jun 9, 2015). Affected quantity: 190 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 27, 2014
- Initiation Date
- Jul 1, 2014
- Termination Date
- Jun 9, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 190 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
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.
Code Information
Item Number 00-5908-015-00, Lot Numbers: 56519125 & 56518861
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2289-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026