Zimmer, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2289-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: July 1, 2014

Date Posted: August 27, 2014

Recall Number: Z-2289-2014

Event ID: 68653

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.

Status: Terminated

Product Quantity: 190 units

Code Information:

Item Number 00-5908-015-00, Lot Numbers: 56519125 & 56518861

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.

Voluntary or Mandated:

Voluntary: Firm initiated