Zimmer Recalls Persona Knee Instrument Trays Due to Sterilization Risk
Zimmer, Inc. is recalling 190 non-sterile Persona Tibial General Instrument Trays because a geometry defect may prevent proper sterilization of included drill guides.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product where improper sterilization could lead to infection, but no injuries or illnesses have been reported, fitting the High severity criteria.
Plain-English summary
Zimmer, Inc. is recalling 190 units of the PERSONA (TM) The Personalized Knee System Tibial General Instrument Tray, non-sterile. The recall involves Item Number 00-5907-015-00 and Lot Numbers 56518863 and 56518862. These trays are intended to organize, store, and protect surgical instruments during transport and circulation in hospital or surgical center settings.
The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry required to accommodate the tibial drill and stop guide with proper position and orientation. This geometry mismatch means the drill bracket and drill guide may not fit correctly in the Persona Fixed Case Kit, which could lead to improper sterilization of the tibial drill and stop guide.
The affected units were distributed worldwide, including in the United States (AZ, CA, CO, FL, IL, IN, KS, MI, MN, NC, NJ, NY, OH, OR, PA, TN, TX, and VA) and internationally to Australia, France, India, Italy, and Germany. Healthcare facilities should stop using the affected trays and contact Zimmer, Inc. for instructions on return or replacement.
The recalled product
- 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…
- Manufacturer
- Zimmer, Inc.
- Affected units
- 190
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Item Number 00-5907-015-00
- Lot Numbers: 56518863 & 56518862
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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Similar recalls
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