Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defect
Zimmer, Inc. is recalling Trilogy Acetabular Shells because some units may have porosity below the specified range, potentially affecting the device's performance.
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 is classified as FDA Class II, which falls under the 'High' severity category in the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling the Trilogy Acetabular Shell with Cluster Holes, a medical device indicated for cemented or uncemented use in hip rehabilitation surgery. The recall involves 275,952 units that were distributed worldwide, including in the United States and numerous international markets.
The recall is being conducted because some units manufactured since March 2009 may have porosity levels below the lower range of the specification, with some units as low as 28% compared to the 30% porosity specification. On October 31, 2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
This is an FDA Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. Healthcare providers and patients should contact Zimmer, Inc. for further instructions regarding the affected devices.
The recalled product
- Product
- Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
- Manufacturer
- Zimmer, Inc.
- 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.
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