Agency classClass IIOur severity:High FDA (Devices)·Z-0772-2013·Announced 2013-02-13

Zimmer Recalls Trilogy Acetabular Shells for Porosity Specification Defects

Zimmer, Inc. is recalling Trilogy Acetabular Shell Spiked units because some may have porosity levels below the required specification.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 a structural defect (porosity specification) that poses a risk of harm, but the source text does not report any 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 Acetabular Shell Spiked. The product is indicated for cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. 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 manufactured since March 2009 may be below the lower range of the pore size specification. Specifically, some units may have porosity as low as 28%, whereas the specification requires 30%.

The affected units were distributed nationwide in the United States and in numerous international countries, including Denmark, Germany, Greece, Hungary, Ireland, Italy, the Netherlands, Spain, Sweden, the UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and the UAE. Consumers and healthcare providers should contact Zimmer, Inc. for further instructions regarding the recall.

The recalled product

Product: Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: structural-defect
porosity-specification
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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