Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray Recalled by Zimmer, Inc. Due to The firm discovered that the current Personal Tibial/General...

Date: July 1, 2014
Company: Zimmer, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer, Inc. directly.

Affected Products

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.

Quantity: 190 units

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 18 states: AZ, CA, CO, FL, IL, IN, KS, MI, MN, NJ, NY, NC, OH, OR, PA, TN, TX, VA

Affected (18 states)Not affected

About Zimmer, Inc.

Zimmer, Inc. has 437 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report