The Recall Desk
HighFDA (Devices)·Z-2578-2014·Announced 2014-09-10

Zimmer Persona Knee Trial Articular Surface Provisional Breakage Recall

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 is classified as FDA Class II. The hazard involves breakage of a medical device used in surgery, which poses a risk of harm, but the source does not report specific injuries or fatalities, fitting the criteria for a high-risk product where injury has not yet been reported or is remote.

Plain-English summary

Zimmer, Inc. is recalling 77,737 units of the PERSONA The Personalized Knee System Tibial Articular Surface Provisional (TASP). The recall covers various sizes and thicknesses for both left and right knees, distributed worldwide including the United States and multiple international markets.

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 affected products are identified by specific part numbers and numerous lot numbers listed in the official recall documentation. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote.

The recalled product

Product
PERSONA The Personalized Knee System Tibial Articular Surface Provisional Left with the following: Size CD +0 mm Thickness Bottom(TB); Size CD +6 mm Thickness Bottom; Size EF +0 mm Thickness Bottom; Size EF +6 mm TB; Size GH +0 mm TB; Size GH +6 mm TB; Size J +0 mm TB; Size 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: 42517000303
  • 42517000313
  • 42517000505
  • 42517000515
  • 42517000707
  • 42517000717
  • 42517000909
  • 42517000919
  • 42527000303
  • 42527000313
  • 42527000505
  • 42527000515
  • 42527000707
  • 42527000717
  • 42527000909
  • and 42527000919. Lot numbers:62022340
  • 62024973
  • 62062232
  • 62104367
  • 62187314

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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