Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defects
Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells with Uni-Hole because some units 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, and the source text does not report any illnesses or injuries, fitting the rubric 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 with Uni-Hole. These medical devices are indicated for cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
The recall was initiated because some units manufactured since March 2009 may have porosity levels below the lower range of the specification, measuring as low as 28% compared to the required 30%. On October 31, 2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
The affected products were distributed nationwide in the United States and in numerous international locations, 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. Healthcare providers and patients should contact Zimmer, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Trilogy F/M Acetabular Shell with Uni-Hole. 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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