The Recall Desk
HighFDA (Devices)·Z-2289-2014·Announced 2014-08-27

Zimmer Recalls Persona Knee Instrument Trays Due to Sterilization Risk

Zimmer, Inc. is recalling 190 units of Persona Tibial General Instrument Trays because incorrect bracket geometry may prevent proper sterilization of surgical instruments.

What this means for you

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 (improper sterilization of surgical instruments) where injury has not yet been reported, fitting the criteria for a High severity score.

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 00-5908-015-00, specifically Lot Numbers 56519125 and 56518861. These products were distributed worldwide, including in the United States and internationally to Australia, France, India, Italy, and Germany.

The firm discovered that the 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 incorrect geometry in the drill bracket and drill guide prevents a proper fit in the Persona Fixed Case Kit, which could lead to improper sterilization of the tibial drill and stop guide.

Healthcare facilities and distributors should stop using the affected trays and contact Zimmer, Inc. for further instructions. The intended use of the sterilization case is to organize, store, and protect its contents from damage during circulation in hospitals or surgical centers and during transport between a Zimmer distributorship and a health care facility.

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 ser
Manufacturer
Zimmer, Inc.
Category
Medical Device — Surgical Instruments
Hazard
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 00-5908-015-00
  • Lot Numbers: 56519125 & 56518861

Distribution

Distributed in 18 states:

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.

See all 2 products in this recall →

Related recalls

Same manufacturer · Zimmer, Inc.

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Same hazard · improper sterilization

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