Recall Z-2289-2014— Zimmer, Inc.

Class II FDA medical device recall by Zimmer, Inc., initiated 2014-07-01, terminated 2015-06-09. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..

Recalling firm

Zimmer, Inc.

Classification

Class II

Status

Terminated

Initiated

2014-07-01

Terminated

2015-06-09

Firm location

Warsaw, IN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.