Zimmer Recalls Trilogy Acetabular Shells for Porosity Defects
Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells because some units have porosity levels below the specified range. The recall includes units manufactured since March 2009 and was expanded in October 2012.
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 typically corresponds to a High severity score (3) when no specific hospitalizations or deaths are reported in the source text. The defect involves a deviation from porosity specifications, which is a significant quality issue for an implanted medical device.
Plain-English summary
Zimmer, Inc. is recalling specific units of the Trilogy F/M Acetabular Shell without holes SOLID HA. The recall covers shells with outer diameters ranging from 38MM to 70MM. 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. Specifically, some units may have porosity as low as 28%, whereas the specification requires 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 worldwide, including the United States 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. A total of 275,952 units are involved in this recall. Healthcare providers and patients should contact Zimmer, Inc. for further instructions regarding the removal or replacement of these devices.
The recalled product
- Product
- Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 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…
- 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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