The Recall Desk
HighFDA (Devices)·Z-2300-2014·Announced 2014-08-27

Zimmer Recalls Persona Knee Trial Components Due to Breakage Complaints

Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals because of reported breakage. The recall covers 70,986 distribution events worldwide.

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 is classified as FDA Class II, and the source text reports breakage of the device components. Under the rubric, a risk-of-harm product where injury has not yet been explicitly reported (only breakage complaints) corresponds to a score of 3 (High).

Plain-English summary

Zimmer, Inc. is recalling specific lots of the Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom components. The recall is triggered by complaints reporting breakage of these trial components. This is a retrospective recall covering corrective actions taken by the company earlier in the year.

The affected products are nonsterile trial components used during knee surgery. The recall includes 70,986 distribution events. Distribution was worldwide, including the United States (nationwide, DC, and Puerto Rico) and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.

Healthcare providers and facilities should stop using the affected components and contact Zimmer, Inc. for instructions on return or replacement. The specific item numbers and lot numbers are listed in the official recall documentation.

The recalled product

Product
Persona (TM) The Personalized Knee System Tibial Articular Surface Provisional Bottom Nonsterile PSN A/S PROV L CD BOTTOM +0MM PSN A/S PROV L CD BOTTOM +6MM PSN A/S PROV L EF BOTTOM +0MM PSN A/S PROV L EF BOTTOM +6MM PSN A/S PROV L GH BOTTOM +0MM PSN A/S PROV L GH BOTTOM
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
70,986

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 (15)

  • Item Numbers: 42517600303
  • 42517600313
  • 42517600505
  • 42517600515
  • 42517600707
  • 42517600717
  • 42517600909
  • 42517600919
  • 42527600303
  • 42527600313
  • 42527600505
  • 42527600515
  • 42527600707
  • 42527600717
  • 42527600909

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

Part of a larger recall action

This product is one of 6 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 6 products in this recall →

Related recalls

Same manufacturer · Zimmer, Inc.

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Same hazard · device breakage

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