The Recall Desk
HighFDA (Devices)·Z-0769-2013·Announced 2013-02-13

Zimmer Recalls Trilogy Acetabular Shells for Porosity Defect

Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells because some units have porosity below the specified range. The recall includes 275,952 units distributed worldwide.

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 a structural defect (porosity) in an implanted medical device, which poses a risk of harm, but the source text does not report specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zimmer, Inc. is recalling 275,952 units of Trilogy F/M Acetabular Shells without holes. The affected shells are available in various outer diameters ranging from 40MM to 70MM. The recall was expanded on October 31, 2012, to include lots of Uni-Hole Trilogy Acetabular System shells.

The recall is due to a manufacturing defect where some units produced since March 2009 may have porosity levels below the lower range of the specification. Specifically, some units may have porosity as low as 28%, whereas the specification requires 30% porosity.

The affected products were distributed nationwide in the United States and internationally in Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE. Healthcare providers and patients should contact Zimmer, Inc. for further instructions regarding the replacement or return of these devices.

The recalled product

Product
Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for reha
Manufacturer
Zimmer, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
275,952

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

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