The Recall Desk
HighFDA (Devices)·Z-2580-2014·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 no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Zimmer, Inc. is recalling 77,737 units of the PERSONA The Personalized Knee System UC Tibial Articular Surface Provisional (TASP) instruments. The recall covers various sizes and configurations for both left and right knees, including CD, EF, GH, and J Top models. The affected products were distributed worldwide, including nationwide in the United States and in numerous international countries.

The recall was initiated 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 is intended to ensure that all distributors and users of the instrument are aware of the enhanced surgical techniques.

The recall involves specific part numbers and a large list of lot numbers. Users and distributors should be aware of the updated surgical techniques and the potential for instrument breakage.

The recalled product

Product
PERSONA" The Personalized Knee System UC Tibial Articular Surface Provisional Left Size 3-7 CD Top; Left Size 4-11 EF Top; Left Size 7-12 GH Top; Left Size 9-12 J Top; Right Size 3-7 CD Top; Right Size 4-11 EF Top; Right Size 7-12 GH Top; and Right Size 9-12 J Top.
Manufacturer
Zimmer, Inc.
Category
Medical Device — Surgical Instrument
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: 42517200410
  • 42517200510
  • 42517200610
  • 42517200710
  • 42527200410
  • 42527200510
  • 42527200610
  • and 42527200710. Lot numbers:62034570
  • 62117742
  • 62156315
  • 62187322
  • 62247350
  • 62314721
  • 62372409
  • 62381836
  • 62397160
  • 62429190
  • 62474906
  • 62551390
  • 62565048

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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