FDA Medical Device Recalls (openFDA)
Zimmer, Inc.: 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.
- Recall number
- Z-2289-2014
- Recalling firm
- Zimmer, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2014-07-01
- Posted
- 2014-08-20
- Terminated
- 2015-06-09
- 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.
- 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
- 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.
- Lot, serial or model codes
- Item Number 00-5908-015-00, Lot Numbers: 56519125 & 56518861
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FSM
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28