The Recall Desk
HighFDA (Devices)·Z-2579-2014·Announced 2014-09-10

Zimmer Persona Knee Trial Articular Surface Provisionals Recalled for 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 to patients, but the source text does not explicitly report injuries, hospitalizations, or deaths, nor is it classified as FDA Class I.

Plain-English summary

Zimmer, Inc. is recalling 77,737 units of the PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional (TASP) components. The recall involves specific left and right sizes and part numbers, including various CD, EF, GH, and J Top configurations. These medical devices are distributed worldwide, including across the United States and in multiple international markets such as Australia, India, Japan, and the United Kingdom.

The recall is being conducted due to reports of breakage of the Persona Knee Trial Articular Surface Provisionals. 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.

The affected products are identified by specific part numbers and a long list of lot numbers provided in the recall documentation. Consumers and healthcare providers should verify their inventory against the provided part and lot numbers. Users should be aware of the updated surgical techniques associated with the Persona primary knee system.

The recalled product

Product
PERSONA The Personalized Knee System PS Tibial Articular Surface Provisional Left with Size 3-5 CD Top; Size 6-9 CD Top; Size 3-5 EF Top; Size 6-9 EF Top; Size 10-11 EF Top; Size 6-9 GH Top; Size 10-12 GH Top; Size 10-12 J Top; and RIGHT Size 3-5 CD Top; Right Size 6-9 CD Top; Ri
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: 42517400410
  • 42517400510
  • 42517400610
  • 42517400710
  • 42517400810
  • 42517400910
  • 42517401010
  • 42517401110
  • 42527400410
  • 42527400510
  • 42527400610
  • 42527400710
  • 42527400810
  • 42527400910
  • 42527401010
  • and 42527401110. Lot numbers:62043556
  • 62110045
  • 62121489
  • 62125589
  • 62147235

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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