CLASS II Device recall · Reported 27 Aug 2014 · FDA Enforcement Report
Persona (TM) The Personalized Knee System Tibial General recalled
Zimmer is recalling Persona (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The, distributed nationwide in the US. The recall was initiated on 1 Jul 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2288-2014
- FDA event ID
- 68653
- Recalling firm
- Zimmer, Warsaw, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Jul 2014
- FDA classified
- 20 Aug 2014
- Reported
- 27 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Heart & Vascular Devices
Timeline
| 1 Jul 2014 | Recall initiated by company | |
| 20 Aug 2014 | Classified by FDA | +50 days |
| 27 Aug 2014 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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.
Where it was distributed
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.
Nationwide ArizonaCaliforniaColoradoFloridaIllinoisIndianaKansasMichiganMinnesotaNorth CarolinaNew JerseyNew YorkOhioOregonPennsylvaniaTennesseeTexasVirginia
Questions about this recall
Is Persona (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The recalled?
Yes. Zimmer recalled Persona (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile The on 1 Jul 2014. The recall is Class II and its status is Terminated. Recall number Z-2288-2014.
Why was it 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.
Which lots are affected?
Item Number 00-5907-015-00, Lot Numbers: 56518863 & 56518862
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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