PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilizat

FDA device recall Z-2289-2014 · posted 2014-08-20 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

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.

Action taken

On July 1, 2014, Zimmer, Inc. issued recall notification to their consignees via e-mail and/or letter. Notification included affected product issue and instructions for returning the affected product. All distributors were notified via electronic mail. Hospital risk managers, as well as distributors with affected inventory were also notified via courier. Distributors were sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the affected product in their territory. Distributors are responsible for returning on-hand affected products to Zimmer and ensuring all of their products are accounted for using the form provided in the letter. Hospital risk managers were provided with a letter identifying the issue and their responsibilities. These responsibilities include locating the affected product, quarantining the product, and returning it to their Zimmer sales representative.

Root cause

Device Design

Status

Terminated

Product code

FSM

Quantity affected

190 units

Distribution

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.

Date initiated

2014-07-01

Date posted

2014-08-20

Date terminated

2015-06-09

Location

Warsaw, IN