The Recall Desk
HighFDA (Devices)·Z-2576-2014·Announced 2014-09-10

Zimmer Persona Knee Trial Articular Surface Provisional Recall for Breakage

Zimmer, Inc. is recalling 77,737 Persona Knee Trial Articular Surface Provisional units 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 reported breakage, which poses a risk of harm during surgery, but no specific injuries or fatalities are reported in the source text.

Plain-English summary

Zimmer, Inc. is recalling 77,737 units of the PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP. The recall is being conducted due to reports of breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). The company has also updated the Persona primary knee surgical technique, and this field action is intended to ensure that all distributors and users are aware of the enhanced surgical techniques.

The affected products are distributed worldwide, including nationwide in the United States and in specific countries such as Australia, India, Japan, Korea, Singapore, Austria, Belgium, France, Germany, Israel, Italy, Luxembourg, Netherlands, Saudi Arabia, South Africa, Spain, Switzerland, United Kingdom, and United Arab Emirates. The recall covers specific part numbers and lot numbers, which are detailed in the official agency documentation.

Healthcare providers and distributors should stop using the affected trial instruments and follow the instructions provided by Zimmer, Inc. to ensure compliance with the updated surgical techniques and to address the reported breakage issues.

The recalled product

Product
PERSONA The Personalized Knee System Constrained Posterior Stabilized Tibial Articular Surface Provisional TOP with the following: L 3-5 CD; L 6-9 CD; L 3-5 EF; L 6-9 EF; L 10-11 EF; L 6-9 GH; L 10-12 GH; L 10-12 J; R 3-5 CD; R 6-9 CD; R 3-5 EF; R 6-9 EF; R 10-11 EF; R 6-9 GH; R
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: 42517600410
  • 42517600510
  • 42517600610
  • 42517600710
  • 42517600810
  • 42517600910
  • 42517601010
  • 42517601110
  • 42527600410
  • 42527600510
  • 42527600610
  • 42527600710
  • 42527600810
  • 42527600910
  • 42527601010
  • and 42527601110. Lot numbers: 62342526
  • 62423918
  • 62423919
  • 62423920
  • 62427414

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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