The Recall Desk
SevereFDA (Devices)·Z-2575-2014·Announced 2014-09-10

Zimmer Persona Knee Trial Articular Surface Provisional Breakage Recall

Zimmer, Inc. is recalling Persona Knee Trial Articular Surface Provisionals due to reports of breakage and updated surgical techniques.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves reports of breakage of a medical device used in knee surgery, which poses a risk of significant injury.

Plain-English summary

Zimmer, Inc. is recalling the PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM. The recall involves 77,737 units distributed worldwide, including the United States and various international markets. The affected part numbers and lot numbers are listed in the structured product information.

The recall is being conducted due to reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). Additionally, the Persona primary knee surgical technique has been updated. This field action correction is intended to ensure that all distributors and users of this instrument are aware of the enhanced surgical techniques.

Consumers and healthcare providers should stop using the affected devices and contact Zimmer, Inc. for further instructions regarding the updated surgical techniques and the recall.

The recalled product

Product
PERSONA The Personalized Knee System Constrained Tibial Articular Surface Provisional BOTTOM with the following: L CD +0MM; L CD +6MM; L EF +0MM;L EF +6MM; L GH +0MM; L GH +6MM; L J +0MM; L J +6MM; R CD +0MM; R CD +6MM; R EF +0MM; R EF +6MM; R GH +0MM; R GH +6MM; R J +0MM; R J
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
77,737

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 (20)

  • Part Numbers: 42517600303
  • 42517600313
  • 42517600505
  • 42517600515
  • 42517600707
  • 42517600717
  • 42517600909
  • 42517600919
  • 42527600303
  • 42527600313
  • 42527600505
  • 42527600515
  • 42527600707
  • 42527600717
  • 42527600909
  • and 42527600919. Lot numbers: 62345370
  • 62402721
  • 62423922
  • 62424796
  • 62494665

Distribution

Distributed nationwide across the United States.

The notice also names 50 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

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Same hazard · breakage

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