Z-2288-2014Class II

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

Name: Z-2288-2014 PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the...
Creator: Zimmer, Inc.
Published: 2014-07-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-07-01 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The intended use of the sterilization case is to organize, store and... on 2014-07-01. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2288-2014
Classification: Class II
Status: Terminated
Initiated: 2014-07-01
Posted: 2014-08-20
Terminated: 2015-06-09
Recalling firm: Zimmer GmbH
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.
Product code: FSM Tray, Surgical, Instrument
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 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.
Product codes and lots: Item Number 00-5907-015-00, Lot Numbers: 56518863 & 56518862

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2288-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2288-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-20
Z-2289-2014	Class II	Terminated	Voluntary: Firm initiated	2014-08-27	2014-08-20

Product code FSM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)