The Recall Desk
HighFDA (Devices)·Z-2577-2014·Announced 2014-09-10

Zimmer Recalls Persona Knee Trial Articular Surface Provisionals Due to Breakage

Zimmer, Inc. is recalling 77,737 units of Persona Knee Trial Articular Surface Provisionals due to reports of breakage and updated surgical techniques.

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 medical device with reports of breakage, which poses a risk of harm during surgery, but the source does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zimmer, Inc. is recalling 77,737 units of the PERSONA The Personalized Knee System CR Tibial Articular Surface Provisionals. The recall is being conducted due to reports of breakage of these trial instruments. The company is also implementing this field action to ensure that all distributors and users are aware of updated surgical techniques for the Persona primary knee system.

The affected products are distributed worldwide, including nationwide in the United States and in numerous countries across Europe, Asia, the Middle East, and other regions. The specific units involved include various Left and Right sizes (3-9, 3-11, 7-12, and 9-12) with specific part numbers and lot numbers listed in the official recall documentation.

Consumers and medical professionals should stop using the affected trial articular surface provisionals and contact Zimmer, Inc. for further instructions regarding the return or replacement of these instruments.

The recalled product

Product
PERSONA The Personalized Knee System CR Tibial Articular Surface Provisional with the following: Left Size 3-9 CD Top; Left Size 3-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Left Size 3-9 CD Top; Left Size 3-11 EF Top; Right Size 7-12 GH Top; and Right Size 9-12 J To
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: 42517000410
  • 42517000510
  • 42517000610
  • 42517000710
  • 42527000410
  • 42527000510
  • 42527000610
  • and 42527000710. Lot numbers: 62024975
  • 62043546
  • 62144792
  • 62152725
  • 62165538
  • 62187318
  • 62337961
  • 62372407
  • 62386776
  • 62397159
  • 62405917
  • 62456263
  • 62499170

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

Same manufacturer · Zimmer, Inc.

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Same hazard · breakage

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