Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defect
Zimmer, Inc. is recalling Trilogy Acetabular AB Shells with Holes because some units may have porosity below the specified range.
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. Per the rubric, a Class II recall without explicit reports of hospitalization or significant injury falls under the 'High' severity category, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Zimmer, Inc. is recalling 275,952 units of Trilogy Acetabular AB Shells with Holes. The recall was expanded on October 31, 2012, to include lots of Uni-Hole Trilogy Acetabular System shells. The product is indicated for cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
The recall is being conducted because 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 products were distributed worldwide, including the United States (nationwide) and numerous international markets such as 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. Patients who have had these implants should contact their healthcare provider for further instructions.
The recalled product
- Product
- Trilogy Acetabular AB Shells with 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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