PERSONA — Class II medical device recall Z-2289-2014
Terminated recall by Zimmer, Inc., reported 2014-08-27, distributed in AZ, CA, CO, FL, IL, IN, KS, MI…. The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geo
| Recall number | Z-2289-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-07-01 |
| Classified | 2014-08-20 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2015-06-09 |
| Distributed | AZ, CA, CO, FL, IL, IN, KS, MI, MN, NC, NJ, NY, OH, OR, PA, TN, TX, VA |
| Countries outside the US | AU, DE, FR, IN, IT |
| Quantity | 190 units |
| Lot numbers | 56518861, 56519125 |
| Model numbers | 00-5908-015-00 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2289-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.